- Last week, the FDA approved the first approved biosimilar in the U.S.—a copycat version of Amgen's Neupogen (filgrastim), developed by Sandoz/Novartis.
- Although Amgen lobbied for stricter regulations of the generics market several years ago, it is now joining the fray and aggressively pursuing biosimilar R&D.
- Based on current operations and program development, Amgen plans to have up to five biosimilars on the market by 2019.
The times are changing. The recent FDA approval of Zarxio (filgrastim-sndz) signaled a significant change in the biologics landscape, as the movement towards biosimilar R&D gains momentum. Although Amgen's Neupogen was copycatted, the company is not coming out against biosimilar development. In contrast, Amgen has ramped up its biologics production capacity, while keeping a multitude of bioreactors busy growing Chinese hamster ovary cells.
Under the aegis of the Affordable Care Act of 2010, the Biologics Price Competition and Innovation Act has made biosimilar development more enticing for biopharma companies, such as Amgen, by creating an abbreviated pathway to approval. Currently, one of the drugs that Amgen is focused on is a biosimilar version of AbbVie's Humira (adalimumab), a $13 billion drug used to treat rheumatoid arthritis and other autoimmune conditions.
In addition, Amgen is working on eight other biosimilars as part of an ambitious and resource-demanding development program. Amgen is counting on returns on its strategic and timely investment.