Regulatory Approach for Biosimilars

Asian Biosimilar 2018 will provide an excellent opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to discuss and learn about the regulatory competencies required for Biosimilars and Biologics.This track includes: Licensing of biosimilars, Biosimilars regulation, Biosimilar Patents , BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars.
Approximately 20% of the biologics and biosimilars in the  worldwide R&D pipelines are facing challenges to fall in line with the regulatory guidelines..

  • Regulatory prospects of BRIC countries
  • Licensing of biosimilars
  • BLA filing for biosimilars
  • A paradigm of traditional generics to biosimilars
  • Patent disputes and litigations
  • Generic Biosimilars
  • Critical regulatory issues

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