Amgen pushes agenda for biosimilars on the FDA

Amgen ($AMGN) has some concerns as the U.S. progresses toward a regulatory pathway for biosimilars development. As one of the largest biotech drugmakers, the company plans to advise the FDA today to adopt standards to guard the safety, supply chain and understanding of the copycat biologics.

The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars. Dr. Joseph Miletich, Amgen's senior vice president of R&D, plans to speak on behalf of his company, which is a major player in the biosimilars game. Besides the company's tie-up with Watson to advance cancer biosimilars, Amgen faces competition from knockoff versions of its biologics.

In a release this morning, Amgen revealed that Miletich plans to push for the agency to adopt rules which would put tracking systems in place and distinguish biosimilars from the originals, make clear to doctors and others that biosimilars aren't substitutes for the real thing unless the FDA deems them interchangeable, and keep high quality standards for production of biosimilar products.

Amgen clearly has an interest in protecting the company's franchise of biotech drugs such as Enbrel, Epogen and Aranesp. The company's deal with Watson excludes development of biosimilar versions of Amgen drugs. Yet there are literally hundreds of companies chomping at the bit to develop copycat version of biologics, if not in the U.S., than in emerging markets. And many have already debuted biosimilar products. 

Biogen Idec ($BIIB), Novartis ($NVS) and other large drugmakers are also investing in biosimilars but have an interest in safeguarding their intellectual property for biologics. Biosimilars are much larger and complex molecules than small-molecule generics, and there are major challenges to developing a copycat version of a biologic with the same properties and risk/benefit profile as the original.

"The biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances," Miletich said in a statement. "It will be essential for FDA to clearly communicate to all stakeholders what biosimilar products are and are not."

- here's Amgen's release