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Pharma Biosimilars 2021

About Conference


Pharma Biosimilars 2021 invites all the participants from all over the world to attend “2nd International Conference on Biosimilars & Pharmaceuticals” (Pharma Biosimilars 2021) slated on Webinar. Which covers on all aspects of the pharmaceutical sciences, manufacturing, quality with strong emphasis on originality and scientific quality?

Conference Series LLC LTD organizes 1000+ Conferences every year across USA, Europe & Asia with support from 1000 more scientific societies and publishes 1000+ Open access journals which contain over 70000 eminent personalities, reputed scientists as editorial board members, 1200 Symposium & Workshops and 5 million followers. Conference Series Ltd invites all the participants across the globe to attend the “2nd International Conference on Biosimilars & Pharmaceutical”

Pharma Biosimilars 2021 conveys recent developments in Pharma drug marketing and production of Pharma drugs and contract manufacturing. A complete knowledge of a scientific discipline that described the effects of Biosimilars drug marketing and Biosimilars Pharma now explores the Scope of Biosimilars drug marketing in industry. Pharma Biosimilars 2021 provides detailed market, technology, and industry analyses to help readers quantify and qualify the market for prescription generic drugs. Important trends are identified and sales forecasts by product categories and major country markets these are based on industry sources and considered assessment of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the generic drug market. The wider economic environment is also considered.

Themes: Exploring and Expanding the Strategies in Pharmacy

Learning object:

Pharma Biosimilars 2021 gives a complete 360-degree overview on Biosimilars Present scenario & Future prospects. Participants will leave the conference with a wealth of new information and an expanded network of contacts.

Biosimilars Conferences developments are maintaining their momentum and the 2021 Biosimilars Conferences programme delves into strategic discussions regarding:

  • Market and regulatory developments in the Europe and globally

  • Enlightened by the perspective of healthcare professionals and patients experiences

  • Pharmacovigilance and clinical practice

  • The impact of Biosimilars on the competitive landscape of biological products

  • Developing Biosimilars & Biobetters

  • Innovator Pharmaceutical Products of Biosimilars

  • Current Challenges and Research trends in Biosimilars & Biologics

  • Biosimilars: Pharmacovigilance and Safety

  • BCS & IVIVC Based Biowaivers

  • Biopharmaceutical

  • Biological Medicines

  • Bioequivalence Assessment

  • Developing Biosimilars & Biobetters

  • Generics and Biosimilars: Industrial Strategy

  • Globalization of Biosimilars

  • GMP, GCP, QC & R&D

  • Innovation and Technology for Biosimilar Development

  • Intellectual Property Rights

  • Novel Drug Delivery Technologies

  • Pharmacology and Drug Development

  • Plant Produced Biosimilars

  • Protein Biotherapeutics and Biosimilars

  • Regulatory Approach for Biosimilars

Learning objectives

  • Update the participants on the current knowledge including regulatory and scientific thinking

  • Deal with regulatory requirements, scientific and operational challenges

  • Exchange experiences and discuss hot topics with experts

  • Frame the current issues and create dialogue

Key Features

  • Meet Regulatory Expectations

  • Devise Strategies

  • Explore different statistical approaches to demonstrate Biosimilarity with the reference product

  • Panel Discussion and Extended Q&A Sessions

  • Open forum to discuss your most critical questions around Biosimilars & Biologics

  • National & International Speakers

  • Networking with National and International Industry stalwarts who will inspire, educate and engage in all the aspects of Biosimilars.

  • Gain insights and enhance your knowledge with Biosimilars Congress 2021.

  • Provides interaction with the world's well known CEO's and Directors of the Pharmaceutical companies.

Join your companions the world over focused on getting some answers concerning Biologics and Biosimilars related advances, which is your single most obvious opportunity to accomplish the greatest gathering of individuals from the Biosimilars society, coordinate shows, scatter information, meet with recurring pattern and potential specialists, make a sprinkle with new research works, and get name affirmation at this Two-day event. Broadly acclaimed speakers, the most recent research, moves, and the most momentum refreshes in Biologics and Biosimilars are indications of this gathering.

Why attend???

Join your peers around the world focused on learning about Biologics and Biosimilars related advances, which is your single best opportunity to reach the largest assemblage of participants from the Biosimilars community, conduct demonstrations, distribute information, meet with current and potential professionals, make a splash with new research works, and receive name recognition at this 2-day event. World-renowned speakers, the most recent research, advances, and the newest updates in Biologics and Biosimilars are hallmarks of this conference.

Target audiences:

Participation Benefits:

  • Keynote introduction alongside connections to excite established researchers.

  • Workshop and symposiums to achieve the biggest array of members from the Pharma / Biotech people group.

  • A wide track of Exhibitor and Sponsor displays to grandstand the new and rising advancements

  • Platform for networking worldwide speculation group to interface with partners in Pharma/Biotech area

  • Links to the political promoting assets keeping in mind the end goal to extend your business and research organize

  • Triumph of Awards, Certificates perceives your sense of duty regarding your calling to empower the incipient research for Young Researcher and Poster Presentation

 

Session and tracks

Track-1: Developing Biosimilars & Biobetters

Biosimilars are surmounting pharmaceutical business division from most recent three decades and deals appear to extend coherently. Advances in the biotechnology prompt to change and exposure of new natural items (Biosimilars) to treat diverse life-debilitating illnesses. Biosimilars are organic medications that are conveyed after expiry of the patent of affirmed pioneer and include Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

Sub Tracks:

  1. Key Aspects in Technical Development

  2. Analysis of the Biosimilar Development Pipeline

  3. Legal Issues and Implementation of the BPCI Act

Track-2: Intellectual Property Rights

The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of Biologics and Biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

Sub Tracks:

  1. Pharma patent scenario

  2. Criteria for patentability and patent claims

  3. Critical research issues

  4. Patentable subject matter

  5. Recent patent disputes and litigations

Track-3: Innovative Approaches for Biosimilars

biosimilar is an organic item very like an affirmed natural item, known as a kind of perspective item, with no clinically significant contrasts as far as wellbeing and viability. In the U.S., if a natural compound exhibits practically identical information to a U.S. Nourishment and Drug Administration (FDA)- authorized item from expository, preclinical and clinical reviews, it will be acknowledged as a biosimilar after termination of trend-setter licenses through a curtailed course. Tradable natural items are likewise Biosimilars, however should meet extra criteria to coordinate the reference item. Interchangeable can be substituted for the reference item without a medicine from a social insurance supplier.

Sub Tracks:

  1. Biosimilar Product Reimbursement and Pricing

  2. Biosimilar Regulatory Updates and Legal Implications

  3. Biosimilar Market Access and Commercialization

Track-4: Regulatory Advances in Biosimilars

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6 percent with one generic competitor, but jumps to 48 percent with two generic competitors, 56 percent with three, 61 percent with four and 67 percent with five generic producers in a market. Within two years of the expiration of the patent for the popular drug Zantac in mid-1997, generic versions accounted for 90 percent of the treatment’s total sales, and the price for patients was about 10 percent of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners received EMEA approval for the first European Biogenerics, two products containing human growth hormone.

Sub Tracks:

  1. Biosimilars regulation

  2. BLA filing for Biosimilars

  3. Regulatory prospects of BRIC countries

  4. Aparadigm of traditional generics to Biosimilars

  5. Biowaiver approval for Biosimilars

  6. Generic Biosimilars

  7. Regulatory Prospects in BRIC countries

Track-5: Legal Issues and BPCI Act

The legal issues pertaining to the follow-on-Biologics and Biosimilars are one of the most aspects that require an open discussion. Before the actual advent of Biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law. By 2002, the FDA had approved 36 new Biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

Sub Tracks:

  1. Implementation of the BPCI Act

  2. Patent protection and infringement issues

  3. Patent negotiation and litigation phase

  4. Market exclusivities

Track-6: Current Agency Expectations for Approval for Biosimilars

Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products increasingly will be entering major markets. So far, more than 20 Biosimilars for a limited number of reference products have been approved in major markets, primarily the European Union. Only two products have been formally approved as Biosimilars in the United States. The parent field of biopharmaceuticals itself continues to exhibit a poor supporting infrastructure of information resources. Those biopharmaceutical and biosimilar information resources that do exist generally are limited in number, diversity, and sophistication.

Sub Tracks

  1. Drug safety of Biosimilars products

  2. Regulatory aspects

  3. Regulatory affairs and IPR of Biosimilars products

Track-7: Novel Drug Delivery Technologies

Biosimilar Engineers and their outsourcing accomplices must know about the picked nation's administrative scene, and have broad information of any current Biosimilar endorsement pathway and the most recent administrative organization rules. Furnishing administrative experts with endorsements of investigation (CoA) for a U.S. - advertised comparator could challenge. As opposed to European practice, U.S. makers tend not to make CoAs accessible to parties required in the production network or bolster the improvement of a contender by discharging CoAs for clumps acquired for clinical trials. Giving family proclamations to the reference item more often than not is acknowledged as an option.

Sub Tracks:

  1. Product Similarity for Biosimilars & Analytical Challenges

  2. Role of Medical Affairs in Biosimilars

  3. Regulatory strategy for generics and Biosimilars

Track-8: USFDA Approved Biosimilars

The European regulatory authorities led with a specially adapted approval procedure to authorize subsequent versions of previously approved Biologics, termed "similar biological medicinal products", or Biosimilars. This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve Biosimilars to those Biologics originally approved through the PHS Act pathway. The FDA gained the authority to approve Biosimilars (including interchangeable that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010.

Sub Tracks:

  1. Biosimilar and Interchangeable Products

  2. Biosimilar Development, Review, and Approval

  3. Prescribing Biosimilar and Interchangeable Products

  4. Biosimilar Product Information

  5. Industry Information and Guidance

Track-9: Consequences of Brexit on Biosimilars

With Europe that paved way to the uptake of Biosimilars over a decade ago, the consequences of Brexit would be potentially harder on UK. Presently UK is no more bound to follow the guidelines of EMA. Also research grants from Innovative Medicines Initiative and Horizon 2020 would no more be available to UK. All the same, EMA has its headquarters in London, UK. The thus arising complications would definitely have certain consequences on the Biosimilars scenario in UK and EU.

Sub Tracks:

  1. Brexit- Pros and Cons to European pharma market

  2. Post Brexit changes in Biosimilars regulation in UK

  3. Fate of Biosimilars clinical trials in UK

  4. Research funding from European organizations to UK based research laboratories

Track-10: Biosimilars Market Strategy

Effective management of a current good manufacturing practice (GMP) facility requires a strict eye on all those factors. This also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs. Analysis of Biosimilars and Biologics forms to be one of the most important aspects towards the Biologics and Biosimilar development process. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry. The market for Biosimilars follow-on-Biologics is expected to grow at an exponential rate for next decade with the expiry of most patented drugs by 2020.The market in the APAC region for Biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for Biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

SubTracks:

  1. Biosimilar bioanalytical methods

  2. Biosimilar Formulation

  3. Bioassay for comparability and Potency Testing

  4. Biosimilar GMP protein analysis

  5. Biosimilar lc/ms analysis for discovery, preclinical, and clinical programs

  6. Biosimilar Electrophoresis

  7. Biosimilar multimodal techniques

  8. Biosimilars companies

Track-11: Emerging Biosimilars in Therapeutics

Biosimilars Market is experiencing a growth at an exponential rate. Presently around 700 Biologics are making progress in the research pipelines of nearly 250 Biopharma companies. Biosimilar insulins have already started revolutionizing the future drug development in the realm of diabetology. Biosimilars of Adalimumab, Etanercept, Rituximab, Peg-Filgrastim, Trastuzumab are expected to hit the market soon. Biosimilar of Humatrope, biosimilar of Eprex, biosimilar of Neupogen, biosimilar of Remicade have already been enjoying a greater market share in Europe than the reference product itself. The proportion of different Biosimilars that reached market are Low Molecular Weight Heparins 44%, Epoetins 19%, HGH 11%, G-CSFs 7%, Interferons 6%, Insulins 5%, Others 8%.

SubTracks:

  1. Biologics in cancer

  2. Biologics for psoriasis

  3. Biosimilar monoclonal antibodies

  4. Recombinant therapeutic proteins

  5. Insulin Biosimilars

  6. Biologics in autoimmune disease

Track-12: Challenges in Biosimilars

The generic version of Biologicals- “Biosimilars” is the new buzz word in the world of pharmaceutical industry. Biosimilars are highly similar to their licensed reference product not withstanding minor differences as excipients in the formulation; also there are no remarkable differences between the Biologicals and the reference product in terms of safety, purity, and potency. However, there are certain challenges in way of its development and receiving a green signal for launching into the market. Newer Biologics also are targeting widespread diseases, with profound implications: a drug that costs $20,000 per year that is useful for 1 person in 100,000 has much less effect on a health plan’s cost structure than a $5,000-per-year drug that is useful for 1 in 100 people.

SubTracks:

  1. Current concepts of drugs and Biologics

  2. Unique considerations for Biologics

  3. Early clinical development essentials

  4. Late clinical development essentials

  5. Drug safety essentials

  6. Cancer Therapeutics

  7. Comparability for Biologics

  8. Quality by Design for Biologics and Biosimilars

Track-13: Chemical and Analytical Strategies for Biosimilars

Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchange ability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of Biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of Biologics and Biosimilars products. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.

While small changes in these parameters can impact the various chemical permutations for a given bio therapeutic, innovators can, under certain circumstances, change the host cell, fermentation process, purification process, and even manufacturing site, but the product can be validated without undertaking a complete new product development review.

SubTracks:

  1. Biosimilars multimodal techniques

  2. Biosimilars bioanalytical methods

  3. Bioassay for comparability and potency testing

  4. Biosimilars LC/MS analysis for discovery, preclinical and clinical programs

  5. Biosimilars GMP protein analysis

  6. Biosimilars electrophoresis

Track-14: Bioequivalence Assessment

Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar drug. Of all attempts towards developing a follow on Biologics or a biosimilar drug the main detection point stands at the Bioequivalence Assessment. Once the bioequivalence has been obtained it can be 70% ascertained the drug qualifies to be a suitable Biologics or Biosimilars.

Sub Tracks:

  1. Strategies for the bioequivalence assessment of topical dosage forms

  2. Bioequivalence assessment of respiratory dosage forms

  3. Bioequivalence approaches for transdermal dosage forms

  4. Evaluation of highly variable drugs and drug products

Track-15: Biological Medicines

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Disease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

Sub Tracks:

  1. Advances in Biological products

  2. Biological drugs

  3. Generic Biological drugs

  4. Biotechnology medicinal products for different drugs

  5. Future of next generation Biosimilars

  6. Biopharmaceuticals development

Track-16: Biosimilars Approval to Biogenerics in Clinical Practice

Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on Biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a Biosimilars. According to current literature, the following points on Biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of Biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on Biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to allow physicians to gain confidence in Biosimilars.

SubTracks:

  1. Biotechnologic drug

  2. Monoclonal antibody

  3. Fusion protein

  4. Biologic drug

  5. Anti–tumor necrosis factor

Track-17: Biopharmaceutical

Biopharmaceutical are also called medical product these Biopharmaceuticals includes blood, blood components, gene therapy, Recombinant therapeutic protein. Biopharmaceutical informatics is used in information technology, molecular modeling and biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence

Sub Tracks:

  1. Applications of computation in Biologic drug development

  2. Protein sequence-structural contexts and degradation reaction mechanisms

  3. Creation of databases and data mining

  4. Pre-clinical immunogenicity risk assessment of Biotherapeutics

  5. Monoclonal antibodies (Various)

  6. Blood components

  7. Vaccines

  8. Biopharmaceutical Research

Track-18: BCS & IVIVC Based Biowaivers

The objective of this track is to suggest the Biowaivers potential of Biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and Invitro and Invivo classification discusses about ADME pathways of different drugs. This track also includes BCS biowaivers, in vitro diffusion cells for dissolution testing in formulation development, in vitro preclinical ADME/BCS testing. Until in vitro in vivo correlation achieves the required degree, the Biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

Sub Tracks:

  1. BCS biowaivers

  2. Preclinical and clinical testing for oral drug delivery

  3. Waiver for In vivo Bioavailability or Bioequivalence

  4. Consideration of Biowaiver extensions for BCS class III drugs

  5. In vitro diffusion cells for dissolution testing in formulation development

  6. Dissolution testing in drug formulation

  7. In vitro preclinical ADME/BCS testing

  8. In vitro drug product research

Track-19: Pharmacovigilance Challenges and Safety

Biosimilar guidelines for Pharmacovigilance practice and Pharmacoepidemiology are the points that shall be laid emphasis in this session. U.S. average annual spending growth from 2002 to 2007 was 16% for Biologics, compared with 3.7% for drugs. In same proportion Pharmacovigilance for Biosimilars has been comparatively more than other pharmaceutical products. Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in Pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

SubTracks:

  1. Current problems in Pharmacovigilance

  2. Adverse drug reactions with Pharmaceutical products

  3. Detection and evaluation of drug safety signals

  4. Improve Pharmacovigilance through Patient and Provider Education

  5. Regulatory updates and key drivers for registration approvals in US, EU and China

  6. Regulatory requirement for Biosimilar IND filing in the US

  7. Role of Pharma industries in the improvement of Pharmacovigilance system

Track-20: Generic Biosimilars: Industrial Strategy

The "Generic Drugs Market: 2015 - 2030 - Opportunities, Challenges, Strategies & Forecasts" report presents an in-depth assessment of the generic drugs and Analysis of key therapeutic areas and leading generic drugs  pufecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, Pharmaceutical Industry  opportunities, future road map, Following key trends, market drivers, challenges, Analysis of key therapeutic areas and leading generic trends ,value chain, ecosystem player profiles and strategies and  Regulatory landscape of global trends  throughout the globe The report also presents market size forecasts for generic drugs from 2017 through to 2030. The forecasts are segmented for over 10 therapeutic areas, 3 brand classifications, 5 regions and 25 leading countries.

Sub Tracks:

  1. Clinical development strategies for Biosimilars

  2. Advances in Biosimilar Production & Technologies

  3. Scale Up of Biosimilars

  4. Business Development in biosimilar

  5. Major market trends & Featured regional market trends

Track-21: Formulation Strategies for Follow-on Biologics

For this rapidly growing industry sector, little consensus or authoritative information is available yet regarding how and where biosimilar products will be produced. The future of their manufacturing is still up in the air. Much discussion among experts has focused on a dramatic up-tick in Contract Manufacturing Organizations (CMOs) involvement with process development projects and clinical-scale manufacturing for Biosimilars. None have really set up commercial-scale projects (yet), however. Many such companies are publicly discussing large-scale partnerships for production in India and elsewhere in Asia. On the other hand, some Biosimilars sponsors are establishing relationships with smaller biotech CMOs that have demonstrated expertise in efficiency or lower-cost business models

Sub Tracks

  1. Multiproduct or dedicated single product plants

  2. Major markets or developing countries

  3. Single-use, stainless steel or hybrid

  4. Continuous bioprocessing

Track-22: Pharmacology and Drug Development

Pharmacology is the branch of solution and science worried with the investigation of medication action where a medication can be comprehensively characterized as any man-made, characteristic, or endogenous (from inside body) particle which applies a biochemical and additionally physiological impact on the cell, tissue, organ, or living being (once in a while the word Pharmacon is utilized as a term to envelop these endogenous and exogenous bioactive species). Sedate improvement is the way toward conveying another pharmaceutical medication to the market once a lead compound has been distinguished through the procedure of medication revelation. It incorporates pre-clinical research on microorganisms and creatures, petitioning for administrative status, for example, by means of the United States Food and Drug Administration for an investigational new generic medication to start clinical trials on people, and may incorporate the progression of acquiring administrative endorsement with another medication application to showcase the medications and Increase Global Pharma Market

Sub Tracks:

  1. Clinical pharmacology and Drug addictions

  2. Characterization of biologically active compounds

  3. Recent advancements in research and developments

  4. Recent advances in computer aided drug design

  5. Novel Approaches in drug discovery

Track-23: Globalization of Biosimilars

Globalization of Biosimilars is about the generic drugs impact on Global Biosimilar market, Cost and risk management, adopting innovative mechanisms such as risk-sharing arrangement, European market for Biosimilars. A growing global market for Biosimilars is gaining momentum in response to the expiration of patents for a number of key Biologics and consumer demand to reduce treatment costs. Thus, according to Research and Markets, the global biosimilar market, valued at $2 billion in 2012 is projected to reach $19.4 billion by 2018.

Sub Tracks:

  1. Global impact of Biosimilars over generics

  2. Economic aspect towards Biosimilars

  3. Biosimilars in global market

  4. Investment and returns on Biosimilars

  5. Cost and risk management

  6. Adopting innovative mechanisms such as risk-sharing arrangement

  7. European market for Biosimilars

  8. Global P&R models for the Biosimilars and generics market

Track-24: Protein Biotherapeutics and Biosimilars

Biotherapeutics more often than not alludes to helpful materials created utilizing organic means, including recombinant DNA innovation. Biotherapeutics are fundamentally operators, used to treat and maintain a strategic distance from human malady by interrelating with the microbial environment of the host. Biotherapeutics can target particular particles inside the human body, and have a decent reputation with patient wellbeing. Fabricating biotherapeutics is mind boggling, as they are bigger mixes in both size and structure, and can be touchy to ecological conditions.

Sub Tracks:

  1. Advancements in Biotherapeutics

  2. Biotech and Biosimilar Products

  3. Antibody based therapeutics

  4. Therapeutic Antibodies and Fc Fusion Proteins

Track-25: Plant Produced Biosimilars

Biosimilar products are also produced from plants. Plants are the richest store house of diverse class of phytochemicals. Production of Biosimilar products in tobacco plants is on the verge of completion of the first step in their research. These also includes Transgenic plants, Post translational genetics, Fermentation culture, Molecular farming. For biosimilar manufacturers this session has the potential to bring up new avenues in their product range. Pharmacognosy researchers would find this track highly interesting and informative towards their research work. Proportion of plant produced Biosimilars are comparably low. However, an increased level of plant sourced Biologics ~25% is owned to be seen in the market. Especially Biologics derived from the plant sources are expected to occupy about more than 20% of all Biologics.

Sub Tracks:

  1. Transgenic plants

  2. Post translational genetics

  3. Fermentation culture

  4. Molecular farming

Market Analysis:

Biosimilars adoption in developed countries has been mostly payer-driven , based upon payers’ urgency and unmet need to contain public health care expenditures. In today’s emerging markets, biosimilars are still in a status that is nascent, with little to no marked presence. A recent Kantor Health Survey found that 20 percent of emerging market autoimmune patients use a biologic, with the distribution of biologics varying from 29 percent in China to 12 percent in Russia and a mere 6 percent in Brazil.

Biosimilars in USA:

  • USFDA approved the first biosimilar in March 2015 with Sandoz’s Zarxio (filgrastim)

  • Close to 19 pipeline biosimilar molecules are in development phase

  • Bisoimilars represent about 50% of the global biologics market value and generates about 50% of the sales value growth

  • Further approvals would be based on pending legislative decisions on data exclusivity period, naming conventions and interchangeability  

Biosimilars in European Union:

  • By far the largest biosimilar market representing 80% of global biosimilar spending

  • Nineteen biosimilar products authorized in four molecule classes: human growth hormone, erythropoietin, G-CSF and tumour necrosis factor (TNF)-inhibitor

  • About 29 pipeline biosimilars molecules in development

  • Most organized and unambiguous approval pathway

  • Pharmacy level substitution prominently into practice

  • Payer-driven uptake

  • Biosimilars are an integral part of the effective biological therapies available in the EU

Biosimilars in Asia:

  • Asia’s infrastructural availability can vouch for lower biosimilar development costs (e.g., US$11M–$20M in India and US$3M–$10M in China, versus US$100M–$250M in the U.S. and developed countries)

  • Asia countries will require Lower capital expenditure for GMP manufacturing facilities (US$250–$300M in the U.S.; 25–50% cheaper in Japan, India, South Korea and China)

  • Incur Lower labor costs in Asia (4%–73% of the cost of U.S. labor)

  • To date, China and India have approved 96 and 66 follow-on biologics respectively, while Japan and South Korea have approved 9 and 7 biosimilars, respectively

  • China has also provided generous funding, with US$308B allocated from 2010 to 2015 for biotechnology including biosimilars, and an additional US$11.8B earmarked for 2015-2020 to advance innovations in biotech.

 

Past Conference Report

PHARMA BIOSIMILARS 2020, February 12-13, 2020 Auckland, New Zealand

Conference Series LLC Ltd, Scientific Event Organizer and the World Class Open Access Publisher invites all the participants from all over the world to attend “2nd International Conference on Biosimilars & Pharmaceuticals” (Pharma Biosimilars 2020) slated on February 12-13, 2020, Auckland, New Zealand which covers on all aspects of the pharmaceutical sciences, manufacturing, quality with strong emphasis on originality and scientific quality. This Pharma Formulations 2020 setting a platform for all the budding Scientists and Researchers to present their real-time work and share their views and aspects related to the theme of the Conference. The Organizing committee is gearing up for an exciting and informative Conference program including plenary Lectures, Symposia, Workshops on a variety of topics, Poster presentations and various programs for participants from all over the World.

Pharma Biosimilars 2020 conveys recent developments in Pharma drug marketing and production of Pharma drugs and contract manufacturing. A complete knowledge of a scientific discipline that described the effects of Biosimilars drug marketing and Biosimilars Pharma now explores the Scope of Biosimilars drug marketing in industry & provides detailed market, technology, and industry analyses to help readers quantify and qualify the market for prescription generic drugs. Important trends are identified and sales forecasts by product categories and major country markets these are based on industry sources and considered assessment of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the generic drug market. The wider economic environment is also considered.

Why attend Pharma Biosimilars 2020: 

Attending Pharma Biosimilar 2020 is an opportunity for you to meet new people in the field of Pharmaceutical Science.

This Conference enable you to expand your network, you meet people from all walks of life in the same industry. It widens your reach and gets referrals from these people, which can help your business in one way or another. From this perspective, conferences expand your current network and you are bound to build another one.

In Pharma Biosimilar 2020 event, most of the topics talk about the current problems and the long-term solution to it. It does not just talk about the now, but what’s in store for the upcoming years in Pharmaceutical Science field. This event gives you several ideas on the current trends and how to utilize them to your own advantage.

  • Keynote presentation along with interactions to galvanize the scientific community.
  • Workshop and symposiums to reach the largest assemblage of participants from the Pharma/Biotech community.
  • A wide track of exhibitors to showcase the new and emerging technologies.
  • Platform to global investment community to connect with stakeholders in Pharma/Biotech sector.
  • Young Scientist/ Investigators Award geared towards best budding young research.
  • Links to the political marketing resources to expand your business and research network.
  • Triumph of Awards, Certificates recognizes your commitment to your profession to encourage the nascent research.

Pharma Biosimilars 2020 Objective:

Open panel discussions: Providing an open forum with experts from academia and business to discuss on current challenges in Biosimilars & Biologics, where all attendees can interact with the panel followed by a Q&A session.

Speaker and poster presentations: Providing a platform to all academicians and industry professionals to share their research thoughts and findings through a speech or a poster presentation.

Editorial board meeting: Discussing on growth and development of open access Bio-analysis & Biomedicine International Journals and recruiting board members and reviewers who can support the journal.

Round table meetings: Providing a platform where industry professionals meet academic experts.

Over 50+ organizations and international pavilions will be exhibiting at the Pharma Biosimilars 2020 event. Exhibitors will include equipment manufacturers and suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies.

In addition to the products and services you will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.

The Pharma Biosimilars 2020 has everything you need, all under one roof, saving you both time and money. It is the event you cannot afford to miss!!!

 

To Collaborate Scientific Professionals around the World

Conference Date July 13-14, 2021

For Sponsors & Exhibitors

[email protected]

Speaker Opportunity

Past Conference Report

Supported By

Clinical Pharmacology & Biopharmaceutics Journal of Molecular Pharmaceutics & Organic Process Research Clinical Pharmacology & Biopharmaceutics

All accepted abstracts will be published in respective Conference Series LLC LTD International Journals.

Abstracts will be provided with Digital Object Identifier by


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