Amgen applauds the U.S. Food and Drug Administration’s (FDA) decision to hold a Part 15 hearing (Nov 2-3, 2010) and to open a public docket regarding implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In response to the FDA notice for public comments on an “Approval Pathway for Biosimilar and Interchangeable Biological Product,” Amgen submitted written comments to meet the Dec. 31, 2010 deadline.

In its comments, Amgen urged the FDA to establish approval standards that ensure patient safety and follow a science-based approach. Noting the complexities of biological products and the likely differences in products created from different living cells, Amgen outlined the following key principles for the FDA to consider as it moves forward:

• Well-designed clinical trials are needed to establish biosimilarity
• Biologics should not be considered interchangeable until and unless science can and does demonstrate that repeated switching between products would pose no additional risk and present no changes in efficacy for any patients
• Unique nomenclature (including nonproprietary name), numbering (Healthcare Common Procedure Coding System [HCPCS]/National Drug Code [NDC] and lot number), and packaging for each biosimilar product are essential for accurate tracking of all biologics
• Pharmacovigilance signal detection methods should focus on discerning unique characteristics of biological products
• Complete and transparent prescribing information is essential for accurate prescribing and dispensing of biosimilar products
• Education of healthcare professionals about biosimilars is critical

An Executive Summary of Amgen’s comment submission is available here.

Amgen believes the agency should continue to implement the statute in a transparent manner that fosters stakeholder participation. In particular, we urge the FDA to leverage the public guidance development process to formalize its views on the scientific, regulatory and policy issues related to biosimilars. Europe’s experience with biosimilars has shown that robust stakeholder participation can yield clear and useful guidance documents that facilitate adoption of a biosimilar pathway.