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
  • Patent issues
  • BLA filing for biosimilars
  • Regulatory prospects of BRIC countries
  • A paradigm of traditional generics to biosimilars
  • Biowaiver approval for Biosimilars
  • Generic Biosimilars

Related Conference of Regulatory Approach for Biosimilars

October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
February 28-March 01, 2019

Global Pharmaceutical & Pharma Industry Conference

Osaka, Japan
March 18-19, 2019

13th International Conference on Biosimilars and Biologics

Amsterdam | Netherlands
August 5-6, 2019

13th Asian Biologics and Biosimilars Congress

Melbourne, Australia

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