Amgen has spent years defending itself from enemies in the generic drug business, but now the world’s largest biotech company has found a way to join forces with a major maker of copycat pharmaceuticals.
Thousand Oaks, CA-based Amgen (NASDAQ: [[ticker:AMGN]]), which has R&D operations in Seattle, San Francisco, and Boston, said today it has agreed to collaborate with Parsippany, NJ-based Watson Pharmaceuticals (NYSE: [[ticker:WPI]]) to develop and sell targeted antibody drugs for cancer that are “biosimilar” knock-offs of the originals. Watson has agreed to pump as much as $400 million into developing the molecules, while Amgen will contribute its specialized expertise and infrastructure for producing these complex protein drugs that are made in living cells.
The companies didn’t say in today’s joint statement which cancer antibody drugs they will attempt to make as biosimilars. But the companies did say that the partnership will not make lower-cost versions of Amgen’s billion-dollar biotech drugs like etanercept (Enbrel) or epoetin alfa and darbepoetin alfa (Epogen and Aranesp). The biosimilar drugs will be sold under a joint Amgen/Watson label, and Watson will receive royalties and sales milestones from product revenues.
Major biotech companies, like Amgen and Genentech, have argued for years that biologic drugs like theirs can’t be copied in the same straightforward manner as conventional small-molecule chemical compounds like those made by traditional drug companies like Pfizer and Merck. Since biotech drugs are incubated inside living cells that are maintained in carefully controlled bioreactors, much of what makes the product unique is the trade-secret protected manufacturing process that isn’t part of the patent that covers the molecule itself. Tiny alterations to this process can lead to fundamental changes in the product itself, which the big companies have argued requires new clinical trials for “biosimilar” products.
Generic companies have countered that new clinical trials would add too much time and expense to the development process, making it impossible for their biosimiliar products to be offered as cheaply and easily as a new generic version of, say, Pfizer’s atorvastatin (Lipitor). The new business model hasn’t really been established yet in the U.S., but other major drug companies, including Merck, have shown interest in biosimilar drugs that presumably would be cheaper than brand-name originals, but more expensive, and more profitable, than conventional generic pills. More recently, Biogen Idec and Samsung have agreed to collaborate on making biosimilar drugs.
“This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients,” Amgen and Watson said in their joint statement.
Watson is holding a live webcast to discuss the collaboration today at 5 pm Eastern/2 pm Pacific.
