DEC 19 - Amgen Inc, the world's largest biotechnology company, and generic drugmaker Watson Pharmaceuticals Inc, said on Monday they will work together to develop and sell biosimilar versions of several biotech cancer drugs.
The companies, which plan to sell biosimilar products under a joint Amgen/Watson label, did not identify which drugs they are planning to develop cheaper versions of, but said they will not be current Amgen products.
Scott Foraker, head of Amgen's biosimilar division, said the company was fully committed to the effort and expects to see Amgen/Watson biosimilar products on the market in "the second half of this decade."
"Clearly, we're all in," Foraker told Reuters in a telephone interview. "We know exactly which products we're going after. We have detailed product plans and it's fair to say that there has been some work done on some of those products, so we're not starting from scratch."
Amgen, which is already facing competition in Europe from biosimilars of some of its own products, signaled in April that it hoped to utilize its biotech manufacturing expertise to get into the business of biosimilars.
Under terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the biosimilar cancer drugs, the companies said. Watson will contribute up to $400 million in co-development costs and take advantage of its expertise in the sale and marketing of specialty and generic drugs. Watson will initially receive royalties and sales milestones from product revenue.
Amgen's biosimilar efforts, however, will not be limited to the collaboration with Watson.
"Each company has the ability to pursue biosimilars outside of the products we're collaborating on, and I will tell you that you can expect to see biosimilars from Amgen outside the oncology space in other therapeutic areas," Foraker said, declining to identify which other areas.
The U.S. Food and Drug Administration is expected soon to shed more light on a process for the production and approval of less expensive copies of biotech medicines in the United States in an effort to save billions of dollars in health care costs. However, because biologic drugs are far more complex to produce than chemical pills, biosimilars are not expected to be anywhere near as cheap as traditional generic drugs.
"Although the detailed guidance that the FDA is working on has not come out we have a pretty good idea of what their expectations are with respect to product development for biosimilars and they align well with our expectations," Foraker said.
Because medicines produced from living proteins cannot be exactly replicated the way chemical pills can, the products are commonly referred to as biosimilars rather than biogenerics and will require separate FDA guidelines for gaining approval than traditional generic drugs.
"Biosimilars provide an exciting long-term growth opportunity for Amgen. We have a dedicated team to leverage existing capabilities and capacity and drive the success of the collaboration," Amgen Chief Operating Officer Robert Bradaway, who will become CEO next year, said in a statement.
The deal will also allow Watson to gain a major foothold in the field of biosimilars without having to first develop the complex capability of biologic manufacturing.
Several other companies have expressed in interest in getting into the business of biosimilars, including Biogen Idec, Merck & Co, Teva Pharmaceuticals Industries Ltd and Sandoz, the generic unit of Swiss drugmaker Novartis.
(Reporting by Bill Berkrot)
