Amgen, Biogen jump into copycat game amid string of biosimilars deals

Posted under Amgen, Biogen Idec, biosimilars, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Momenta Pharmaceuticals, Pharmaceuticals, Startups, Universities, Videos, Watson Pharmaceuticals by Ryan McBride

With biosilimars coming whether developers of original biologics like it or not, major biotech outfits have changed their tone on the copycat versions of their stock-in-trade and landed deals to grab a piece of the action. Amgen ($AMGN) and Biogen Idec ($BIIB) are two such companies that have inked recent deals, in which the companies aim to bring decades of expertise in creating biotech drugs to help usher in the knockoffs.

The gang of new entrants into the biosimilars game is expected to push investment in the field from $311 million in 2010 to up to $2.5 billion in 2015, The Boston Globe reported today. And the growth comes after a law last year called for the FDA to produce guidelines for developing biosimilars, which, like the originals, are made in living cells, making them more expensive to manufacture and trickier to copy than small molecule drugs. Momenta Pharmaceuticals ($MNTA), for instance, has partnered with Baxter in the biosimilars game and will bring its analytics capabilities to bear to aid in the difficult development process.

"Everyone was resisting it tooth and nail until legislation was passed, but now the starting gun has been fired,'' Momenta CEO Craig Wheeler told the Globe. "I'm personally not of the view that this is going to undermine the industry. I think it's going to spark innovation.''

Biogen and Amgen each revealed their own biosimilars deals late last year, partnering with Samsung and Watson Pharmaceuticals ($WPI) respectively. Both Amgen and Biogen make drugs that face potential competition from copycat versions, especially in Europe, where the regulatory pathway has come into focus faster than in the U.S. There's still a degree of uncertainty about what the FDA will demand of developers of biosimilars, which will be many times more expensive to bring to market that chemical generics.

Biogen is trying to play it smart in the biosimilars game in an effort to enjoy some of the upside of the knockoffs market while continuing to focus on creating originals. And it doesn't plan to copy its own drugs through its partnership with Samsung. "You want to fight biosimilars against your own products,'' Biogen CEO George Scangos told the Globe, "but make them against others.''

- get more in the Globe article

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Posted under Baxter International, biosimilars, Blog, Companies, Diagnostics, Funding, Lovenox, Medical Devices, Medical Supply, Momenta Pharmaceuticals, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Drugmakers and biotech groups continue to partner up in the biosimilars game. With plans to develop up to 6 knockoffs of biologic drugs, Baxter International ($BAX) has agreed to pay Momenta Pharmaceuticals ($MNTA) $33 million in cash and potentially more than $419 million in milestone payments and other fees, according to a representative for Momenta.

Baxter has tapped Momenta, which specializes in making copycat versions of complex drugs, for its expertise in analytics and characterizing biologics, as well as its process development capabilities, according to the companies' release. For its part, Baxter brings to the alliance its strengths in clinical development, manufacturing and commercialization. Biosimilars are generic versions of branded biologics, but the complex structures of biologics present technical challenges to replicating them, making the biosimilars game potentially risker than copying small molecule drugs.

Cambridge, MA-based Momenta has a track record of making difficult-to-copy drugs and has already won FDA approval of a generic version of the clot-buster Lovenox, which is made of thousands of sugar chains. The company says its program focused on biosimilars, or follow-on biologics, stretches the use of its technology for analyzing complex sugars to aid in the development of drugs made of proteins and sugars, or glycoproteins. That said, Baxter and Momenta didn't reveal the specific drugs they plan to develop in their alliance in today's release.

"Baxter's global footprint and extensive development, manufacturing and commercial expertise are exactly what we need to succeed in building a leading follow-on biologics business," Momenta CEO Craig Wheeler said in a statement. Baxter and Momenta plan to close their alliance deal in the first quarter of 2012.

Biosimilar development alliances have been popular this month. First Biogen Idec ($BIIB) and a unit of Samsung announced Dec. 6 a $300 million pact to bring knockoff versions of branded biologics to market, and then Amgen ($AMGN) and Watson Pharmaceuticals ($WPI) revealed plans to develop copycat versions of antibody drugs against cancer on Monday, with Watson agreeing to invest up to $400 million into the effort.

At least in the Amgen-Watson deal, Watson executives said the tie-up would reduce the risks that both companies face in entering the biosimilars business. In the U.S., regulators have yet to provide clear clinical-development requirements for biosimilars.

- here's Momenta and Baxter's release

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Correction: This story was updated and corrected to say that potential milestones and payments in the deal total more than $419 million, not more than $470 million, the erroneous sum that a representative of Momenta gave to FierceBiotech Thursday afternoon. We regret the error. Here's a link to the company's SEC filing on the deal.