Call for Abstract
2nd International Conference on Biosimilars & Pharmaceuticals, will be organized around the theme “Developmental Strategies & New Horizons in Biosimilars through a Decade”
Pharma Biosimilars 2020 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Pharma Biosimilars 2020
Submit your abstract to any of the mentioned tracks.
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Biosimilars/Biologic medicines are large, complex molecules that are made in living cells grown in a laboratory. Biologic medicines are often 200 to 1,000 times the size of a small molecule or chemical drug such as aspirin. Due to both their large molecular size and fragile molecular structure, biologic medicines are almost always injected into the patient’s body.
It is approved based on demonstrating that it is highly similar to a FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
These track discuses 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. The worldwide market situation with the dispatch of first biosimilar in the market gauges some radical changes. This will look upon such key concerns which are seen by the worldwide Pharma advertise and that are thinking of the consequent dispatch of alternate biosimilars and biologics. Despite these rising offices, bio therapeutic designers are most agreeable off-shoring to set up business sectors—the US and Europe. As far as the outsourcing goals that are most-referred to as no less than a probability for outsourcing amid the following five years, the main markets are: USA (78% are at any rate considering) Germany (76%) Singapore (74%) United Kingdom (73%).
Bio-Pharmaceuticals are class of therapeutic protein produced by modern biotechnological techniques, especially via genetic engineering or in the case of monoclonal antibodies by Hybridoma technology.
The Pharmaceuticals industry, as we know it is barely 60years old and now Bio-pharmaceuticals are among the most sophisticated and elegant achievements of modern science, the top 15 biopharma products each enjoy annual revenue of more than $2 billion, with some, such as the anti-inflammatory drug Humira, generating sales of more than $10 billion a year. For many players, the biggest challenge has been simply making enough products to sell. It’s no surprise that major pharmaceutical companies around the world are increasingly shifting their R&D and sourcing focus to large-molecule products.
Pharmaceutical Research and Development (R&D) is crucial for the growth and future success of research-based Pharma companies. To maintain their R&D organisations efficient, pharmaceutical companies started to hedge the potential of open innovation to cut R&D costs and to access external knowledge. These new strategies could be divided into several categories: open source, innovation centres, crowd sourcing and virtual R&D.
A variety of approaches is employed to identify chemical compounds that may be developed and marketed. The current state of the chemical and biological sciences required for pharmaceutical research & development dictates that 5,000–10,000 chemical compounds must undergo laboratory screening for each new drug approved for use in humans. The overall process from discovery to marketing of a drug can take 10 to 15 years. As the product takes shape, the process that began with R&D divides into relevant areas necessary to bring the research product to the market. Regulatory aspects are assessed and work begins to meet all the criteria for approvals and launch.
The goal in biosimilar drug development is to leverage as much information as possible in a stepwise fashion starting with the analytical characterization of the biosimilar compared to the reference product.
The Pharma industry is rapidly changing, which provides a unique set of challenges for those developing and manufacturing biosimilars. Gain true insight on winning development, manufacturing, clinical and commercialization strategies for biosimilars in the global market. Navigate the challenges in the clinic, and the manufacture and development of biosimilar medicines as well as explore the commercial hot topics in the industry. This is your best chance to find out where the true biosimilar industry growth opportunities lie and what role they can play in your portfolio.
An “interchangeable” biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. To be approved as interchangeable, research must show that the biosimilar drug produces the exact same results in an individual patient, that a person can take either drug and expect the same symptom reduction and same side effects. To date, no biosimilars have been approved as interchangeable.
Interchange ability standards:
1. The biological product is biosimilar to the reference product;
2. It can be expected to produce the same clinical result as the reference product in any given patient; and
3. For a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved the current biosimilars development pipeline and update the industry’s progress. Quite a lot has changed in just one and a half years, and it still is early in the evolution of biosimilars, with more progress and changes coming.
Biosimilars in the pipeline are still robust, having grown at an average of greater than 20% annually in the past one and a half years. This sustained growth is remarkable, given that over the past five and a half years the pipeline has expanded at an average of 27% annually.
Bioequivalence Assessment studies are used to compare the expected in vivo biological equivalence of two formulations of a drug and this study is to assure therapeutic equivalence of generic products to innovator products. In the bioequivalence study, bioavailability should be compared for innovator and generic products. If this is not feasible, pharmacological effects supporting therapeutic efficacy or therapeutic effectiveness in major indications should be compared (These comparative tests are hereafter called pharmacodynamics studies and clinical studies, respectively). For oral products, dissolution tests should be performed, since they provide important information concerning bioequivalence.
Bioequivalence assessment includes strategies of topical dosage forms and bio equivalence approaches for transdermal dosage form and assessment of respiratory dosage form.