Amgen and Watson to collaborate on biosimilar anti-cancer drugs

By Dr. Ananya Mandal, MDDec 20 2011

Amgen, the largest standalone biotechnology company, and generic drug firm Watson Pharmaceuticals will collaborate on developing biosimilar drugs for cancer.

In the deal, Watson will contribute $400 million in development costs aimed at making generic versions of “several” anti-cancer drugs that the pair will launch toward the end of the decade. The idea, basically, is that the projects are too expensive and high-risk for one company, and that Amgen will contribute manufacturing expertise while Watson will deliver marketing knowledge.

The pact, however, doesn't keep Watson from pursuing development of biosimilar versions of Amgen products, which include biologics with more than $1 billion in annual revenue such as Enbrel, Epogen and Aranesp. Amgen won a patent for Enbrel last month that could block generic competition to the TNF drug for an extra 17 years, until 2028.

Watson is expected to get royalties and milestones from sales of biosimilars marketed under the deal. A company executive said during a conference call Monday that the biosimilars involved in the pact are expected to hit the European market before the U.S. market, where the availability of the drugs is lower than in Europe.

Pfizer, Merck and Novartis have all said they intend to make a business of selling copycats of biotech drugs, protein medicines that have only been a force in medicine for a little over two decades.

Traditional pills contain relatively easy-to-make molecules. But, in the words of former Genentech researcher Susan Desmond-Hellmann, “our drugs are like steak.” Protein medicines are grown inside genetically modified cells – generally either bacteria or hamster cells – and slight differences in manufacturing can result in unpredictable changes in safety and efficacy. Getting the copycats approved will mean conducting full clinical trials, which in turn means there will be fewer competitors, higher prices, and bigger sales.

“One of our built in advantages is to use the same quality of manufacturing,” says Scott Foraker, the Amgen vice president in charge of biosimilars. “You can trust the new products same way you trusted Amgen biologics over the past 30 years.” Bob Bradway, Amgen's president and chief operating officer, who is expected to become the biotech giant's next CEO, stated, “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.”