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
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- Biosimilars Pipeline
- Challenges in Pharmacovigilance
- Clinical Trials of Biosimilars
- Drug Development and Delivery
- Globalization of Biosimilars
- Intellectual Property Rights
- Legal Issues and BPCI Acts
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