May 16, 2021

Amgen and Watson to Work Together on Generic Drugs

LOS ANGELES — Amgen, the biotechnology company, is planning to develop generic versions of some best-selling drugs.

Amgen said on Monday that it would team up with Watson Pharmaceuticals, a leading generic drug manufacturer, to develop and sell lower-price copycat versions of several biologic cancer drugs.

The companies did not specify which drugs they would develop. But the most likely candidates are the blockbuster products sold by Roche and its Genentech subsidiary — Herceptin for breast cancer, Rituxan for lymphomas and Avastin for various cancers.

Amgen and some other biotechnology companies have long tried to impede the development of generic competition to their drugs, which can cost tens of thousands of dollars a year a patient. They have argued that biologic drugs, which are made in living cells, cannot be precisely copied, unlike drugs made in chemical factories.

But now that pressure to lower health care costs has made such generic competition unavoidable, some of the biotech companies are starting to view it as a natural extension of their business — as long as the cheaper versions they produce are of other companies’ drugs, not their own.

Two weeks ago, Biogen Idec, another leading biotech company, announced a joint venture with Samsung to develop such drugs, which are usually called biosimilars. That partnership will not make copies of any of Biogen’s drugs, and Amgen’s deal with Watson will not copy any Amgen drugs.

While Amgen executives indicated earlier this year that a biosimilar business might make some sense for the company, Monday’s announcement was its formal entry.

“We have purposely been keeping it under wraps as long as we could,” Scott Foraker, who was quietly appointed to head biosimilars at Amgen about a year ago, said in an interview.

Mr. Foraker said Amgen was not being inconsistent, in that it had always said biosimilars have a role, as long as the patent protection on the innovative drug was respected.

Amgen and Watson will split the costs of development roughly in half, with Watson providing up to $400 million in cash or in-kind services. Watson would receive royalties and milestone payments on sales of the drugs.

Mr. Foraker said the deal would allow Amgen to develop biosimilars “in a way that was smart, that didn’t distract the organization from our main innovative business.”

Paul M. Bisaro, chief executive of Watson, said the company had looked at more than 150 potential partners. “We structured the deal with the pre-eminent biologic development company in the world,” he said.

The 2010 law overhauling the health care system orders the Food and Drug Administration to develop rules for the approval of biosimilars. Those rules have not yet emerged, so there is still uncertainty about how extensive clinical trials will have to be.

Amgen and Watson said Amgen would do most of the development, manufacturing and commercialization initially. That is because it is anticipated that biosimilars will need to be marketed, unlike generic drugs.

But over time, the biosimilar market could become more like the market for conventional generic drugs, with competition mainly on price. That would allow Watson to play a greater role.

“Over time, the commercial relationship modifies,” Mr. Bisaro, said. “We both have strengths that make sense for each other no matter how the markets develop.”

Fred Wilkinson, executive vice president of Watson, said his firm would serve as the “conscience” of the partnership, making sure it truly adhered to the idea of making low-cost drugs.

Mr. Bisaro said the drugs might reach the market in the United States around 2018 or 2019, when patents expire. In certain other countries, the drugs could get to the market sooner.

The deal is not exclusive. Watson this year bought a company, Eden Biodesign, that is developing a biosimilar version of a fertility hormone. And Mr. Foraker said Amgen has plans for other biosimilar drugs.

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