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.
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Current Agency Expectations for Approval for Biosimilars Conference Speakers
Recommended Sessions
- Bioequivalence Assessment
- Biological Medicines
- Biological Medicines
- Biosimilars Approval to Biogenerics in Clinical Practice
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- Challenges in Biosimilars
- Chemical and Analytical Strategies for Biosimilars
- Consequences of Brexit on Biosimilars
- Current Agency Expectations for Approval for Biosimilars
- Developing Biosimilars & Biobetters
- Emerging Biosimilars in Therapeutics
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- Intellectual Property Rights
- Legal Issues and BPCI Act
- Novel Drug Delivery Technologies
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- Pharmacology of Cardiovascular Therapeutics - Pharmacology-2024 (France)
- Pharmacology of Neurodegenerative Disorders - Pharmacology-2024 (France)
- Pharmacology of Nutraceuticals and Dietary Supplements - Pharmacology-2024 (France)
- Pharmacology of Pain Management and Analgesia - Pharmacology-2024 (France)
- Pharmacology of Rare Diseases - Pharmacology-2024 (France)
- Pharmacology of Respiratory Diseases: - Pharmacology-2024 (France)
- pharmacotheraphy and drug safety - Pharmacoepidemiology Congress 2024 (Canada)
- Pharmacovigilance and Drug Safety - Clinical-Trials-2024 (Canada)
- Pharmacovigilance and Drug Safety - PHARMA CONFERENCE-2025 (Czech Republic)
- Pharmacovigilance and its Significance - Pharmacoepidemiology Congress 2024 (Canada)
- Pharmacovigilance in the Era of Big Data - Pharmacology-2024 (France)
- Pharmacovigilance Significance and Scope - Pharmacology 2024 (Netherlands)
- Pharmacy Development Services - Pharma Europe 2025 (Italy)
- Pharmacy Education and Practice - PHARMACEUTICAL SCIENCES 2025 (France)
- Photochemistry and Phytopharmaceuticals - PHARMAKON 2025 (Spain)
- Phytochemistry - Natural Products 2024 (Italy)
- Population Health - Personalizedmedicine-2024 (Switzerland)
- Pre-clinical and Clinical Trails - Pharmacology 2024 (Netherlands)
- Precision Medicine - Personalizedmedicine-2024 (Switzerland)
- Precision Medicine and Pharmacogenomics - NURSING PHARMACOLOGY 2024 (Netherlands)
- Public Health and Community Nursing - NURSING PHARMACOLOGY 2024 (Netherlands)
- Purpose and Principles of GMP - PHARMACEUTICAL SCIENCES 2025 (France)
- QC & QA: Quality control and Quality assurance - MedTech-2024 (Switzerland)
- Quality by design(QbD) approach - MedTech-2024 (Switzerland)
- Quality Control and Regulatory Considerations in Drug Delivery Systems - Pharmaceutica-2025 (Canada)
- R&D Advancement: Road to New Medicines - PHARMACEUTICAL SCIENCES 2025 (France)
- Radiation-based medicines and biotherapy - Drug Safety 2024 (France)
- Rational Design of Non-Oral Drugs - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Rational Drug Design and Molecular Modeling - PHARMA CONFERENCE-2025 (Czech Republic)
- Real-World Evidence in Clinical Trials - Pharma Europe 2025 (Italy)
- Recent Advancements in Medicinal Pharma - PHARMA MEDICINAL CHEMISTRY 2025 (Canada)
- Recent advances in drug delivery - Drug Devilvery 2024 (UAE)
- Recent Advances in Pharmacology and Toxicology - Pharmacology 2024 (Netherlands)
- Recent Advances in Pharmacology and Toxicology - Pharmacology 2024 (Netherlands)
- Reformulation Research - Drug Safety 2024 (France)
- Regenerative Medicine and Tissue Engineering - Drug Delivery-2024 (France)
- Regulatory Affairs - Formulations 2024 (Netherlands)
- Regulatory affairs - Pharmacoepidemiology Congress 2024 (Canada)
- Regulatory Affairs and Drug Safety - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Regulatory Affairs and Intellectual Property Rights - Future Pharma 2025 (Netherlands)
- Regulatory Affairs and Quality Assurance in Pharmaceutics - Pharmaceutica-2025 (Canada)
- Regulatory Authority Compliance - MedTech-2024 (Switzerland)
- Regulatory Considerations in Drug Development - Drug Delivery-2024 (France)
- Regulatory Requirements for Pharmaceuticals - PHARMACEUTICAL SCIENCES 2025 (France)
- Regulatory Updates on Biosimilars - Eurobiosimilars 2025 (France)
- Research and development in pharmaceuticals - Drug Safety 2024 (France)
- Research and Trials on Oncology and AIDS - Clinical-Trials-2024 (Canada)
- Risk Management - Pharmacoepidemiology Congress 2024 (Canada)
- Safety of drugs and pharmacovigilance - Drug Safety 2024 (France)
- Safety Pharmacology - Pharmacology 2024 (Netherlands)
- Semi-Solid Dosage Forms - Formulations 2024 (Netherlands)
- Smart Drug Delivery Systems - Pharmatech 2025 (Canada)
- Smart Drug Dery Systems - Formulations 2024 (Netherlands)
- Smart Polymers for Drug Delivery - Pharmaceutica-2025 (Canada)
- Solid Dosage Forms - Formulations 2024 (Netherlands)
- Sustainability and Global Health Biotechnology - Biotech-2025 (France)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Targeted Drug Delivery and Controlled Release Systems - PHARMA CONFERENCE-2025 (Czech Republic)
- Targeted Therapies - Personalizedmedicine-2024 (Switzerland)
- Technologies for Formulation - Drug Safety 2024 (France)
- Technology in Pharma Sciences - MedTech-2024 (Switzerland)
- Telemedicine - Personalizedmedicine-2024 (Switzerland)
- The BBB for drug delivery - Drug Safety 2024 (France)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2024 (Canada)
- Therapeutic Drug Transporters - Drug Safety 2024 (France)
- Toxicology - Pharmacology 2024 (Netherlands)
- Translational Research - Personalizedmedicine-2024 (Switzerland)
- Translational Research in Pharmacology and Therapeutics - NURSING PHARMACOLOGY 2024 (Netherlands)
- Types of Formulations - Formulations 2024 (Netherlands)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (Czech Republic)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (Czech Republic)