May 5, 2015
Earlier this month the Food and Drug Administration (“FDA”) published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”)

1. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009;

2. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and

3. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.

Drafts of the guidances were initially circulated in 2012, after which a comment period followed. The current final guidances reflect input received from the community during the comment period. For businesses operating in the biosimilar space, the recent guidances indicate a more pronounced focus on biosimilars by the FDA and further define what biosimilar pharmaceuticals are and industry standards.

To read the full alert, click here.