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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- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Targeted Drug Delivery and Controlled Release Systems - PHARMA CONFERENCE-2025 (France)
- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2025 (Canada)
- Toxicology - Pharmacology 2025 (France)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Types of Formulations - Formulations 2025 (France)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (France)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (France)