Biosimilars and Biologics

The BPCIA established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a regulatory regime for two sorts of follow-on biologics,termed ”biosimilar” and “interchangeable” biologics. The Food and Drug Administration (FDA) was afforded a prominent role in determining the particular standards for biosimilarity and interchangeability for individual products.

Finally BPCIA created a patent dispute resolution procedure for use by brand- name and follow-on biologic manufacturers

• Implimentation of the BPCI Act
• Patent protection and infringement issues
• Patent negotiation and litigation phase
• Market exclusivities