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