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.

  • Licensing of biosimilars
  • Biosimilars Regulation
  • Patent issues
  • Bio waiver approval for Biosimilars