Current Agency Expectations for Approval for Biosimilars

Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products increasingly will be entering major markets. So far, more than 20 biosimilars for a limited number of reference products have been approved in major markets, primarily the European Union. Only two products have been formally approved as biosimilars in the United States. The parent field of biopharmaceuticals itself continues to exhibit a poor supporting infrastructure of information resources. Those biopharmaceutical and biosimilar information resources that do exist generally are limited in number, diversity, and sophistication.

  • Drug safety of biosimilars products
  • Regulatory aspects
  • Regulatory affairs and IPR of biosimilars products

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