October 7, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, Calif.-based Amgen , faced with generic and biosimilars competition as its blockbusters lose patent protection, is fighting back on a number of fronts.
On Oct. 2, 2015, Novartis announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Enbrel (etanercept). Enbrel is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat various autoimmune disorders, including rheumatoid arthritis and psoriasis.
Sandoz, Inc., a division of Novartis, submitted the BLA using the 351(k) biosimilar pathway. A biosimilar is a drug that acts the same way a known drug does, but has at least a few molecular differences in order to differentiate it from the branded drug.
Amgen sells Enbrel in the U.S., and outside the U.S. by Pfizer Inc. . In 2014, Enbrel had sales of $9 billion. Merck & Co. and Samsung Bioepis have approval for biosimilars of Enbrel in South Korea. Samsung and Biogen, Inc. are trying to get approval for a biosimilar to Enbrel in Europe.
On Sept. 3, 2015, Sandoz announced that its biosimilar, Zarxio, the first biosimilar approved by the FDA, was to launch in the U.S. Zarxio is a biosimilar to Amgen’s Neupogen. Zarxio, however, is not approved as an interchangeable biosimilar. This means that the prescribing physician has to specifically prescribe Zarxio instead of Neupogen. Zarxio has entered the market for about 15 percent less than Neupogen.
Amgen, in addition to litigation, is fighting fire with fire, and developing its own biosimilars. In Feb., Amgen announced positive results for a Phase III study of ABP 501, a biosimilar to AbbVie ’s Humira (adalimumab) in patients with rheumatoid arthritis. In Oct. 2014, the company announced positive Phase III results for the same compound in moderate-to-severe plaque psoriasis.
Just last month, Amgen and Dublin-based Allergan Inc. announced positive results in a Phase III trial for ABP 215, a biosimilar to Roche ’s cancer drug Avastin, used to treat advanced non-squamous non-small cell lung cancer (NSCLC).
Although analysts are doubtful these biosimilars will match the sales of their branded counterparts, they have a good chance of becoming blockbusters. That’s probably a win for consumers, which was the intent of the legislation making biosimilars possible in the U.S., but applies significant pressure on biopharma companies.
Writing for The Motley Fool, Corey Renauer said, “Difficulties associated with biosimilar development and marketing will no doubt limit the number of players, but competitive pricing pressures will likely prevail. This means that the most profitable biosimilar operations will be the ones that can limit costs. Amgen practically wrote the book on modern biologic manufacturing, and a recently constructed next-generation biomanufacturing facility in Singapore will go a long way toward improving profitability.”
In terms of its competition from Novartis, Amgen indicates it’s not done fighting. “We are confident in our Enbrel patent positions, extending to 2029,” said Amgen to BioSpace . “We will seek to enforce our patent rights, in ligitation against Sandoz if necessary, as directed by the provisions of the biosimilars statute.”
