Regulatory Approach for Biosimilars
Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars regulatory prospects of BRIC countries, a paradigm of traditional generics to Biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. Biosimilars 2018 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics with a clear picture of the regulatory approach for biosimilars and biologics.
- Licensing of biosimilars
- Biosimilars regulation
- BLA filing for biosimilars
- Regulatory prospects of BRIC countries
- A paradigm of traditional generics to biosimilars
- Biowaiver approval for Biosimilars
- Generic Biosimilars
- BLA filing for biosimilars
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Regulatory Approach for Biosimilars Conference Speakers
Recommended Sessions
- BCS and IVIVC Based Biowaivers
- Bioequivalence Assessment
- Biopharmaceuticals
- Biosimilars Development
- Biosimilars in Oncology
- Biosimilars in Therapeutics
- Biosimilars Pipeline
- Challenges in Pharmacovigilance
- Clinical Trials of Biosimilars
- Drug Development and Delivery
- Globalization of Biosimilars
- Intellectual Property Rights
- Legal Issues and BPCI Acts
- Regulatory Approach for Biosimilars
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- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)