USFDA Approved Biosimilars

The European regulatory authorities led with a specially adapted approval procedure to authorize subsequent versions of previously approved Biologics, termed "similar biological medicinal products", or Biosimilars. This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve Biosimilars to those Biologics originally approved through the PHS Act pathway. The FDA gained the authority to approve Biosimilars (including interchangeable that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010.

  • Biosimilar and Interchangeable Products
  • Biosimilar Development, Review, and Approval
  • Prescribing Biosimilar and Interchangeable Products
  • Biosimilar Product Information
  • Industry Information and Guidance

Related Conference of USFDA Approved Biosimilars

February 28-March 01, 2019 ANA Crowne Plaza |

Global Pharmaceutical and Pharma Industry Conference

Osaka, Japan
March 18-19, 2019

13th International Conference on Biosimilars and Biologics

Amsterdam | Netherlands
July 26-27, 2019

13th Asian Biologics and Biosimilars Congress

Mercure Albert Park | Melbourne, Australia

USFDA Approved Biosimilars Conference Speakers

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