Merck Says Goodbye to Independent Biosimilars Unit

Merck BioVentures, the biosimilars endeavor set up by Merck & Co. in late 2008, is being subsumed into the biologics and vaccines division of Merck Research Laboratories. Mike Kamarck, who has led BioVentures since 2010, has left the company.

Merck tells In Vivo blog it has "established internal capabilities and external collaborations that create a strong foundation for future progress in the evolving biosimilars sector. As our pipeline of biosimilars and novel biologics continues to progress, we decided to combine development and align under one leader to facilitate decision making and prioritization of resources across the portfolio." That leader is Rich Murray, who is Merck's SVP biologics and vaccines research.

Kamarck's departure is either a blow for the company's biosimilar ambitions or a reflection of reduced expectations and investment for the business. Kamarck has been for the past few years probably the most visible Big Pharma executive on the biosimilars front, and Merck has been -- at least among large, brand-focused pharma companies -- the most bullish on biosimilars' regulatory and commercial prospects.

There have been several bumps in the road. The company's first big biosimilar hopeful was a version of Amgen's Aranesp. That project was discontinued in early 2010. The company also had big plans for its biosimilar version of Enbrel, which it licensed in Phase III from Korea's Hanwha in June 2011. Only a few months later Amgen laid waste to those plans, announcing a 'stealth patent' that could keep Enbrel biosimilars off the market for another 15 years.

Biosimilars may indeed be a new kind of innovation, one that brand-focused biologics companies would be foolish to discount and one they seem to be tripping over themselves to embrace (see Amgen/Watson, Baxter/Momenta, Biogen/Samsung).

Merck's move to reduce its BioVentures group at least in stature seems a step in the other direction and at odds with the bullish attitude of the newly converted and groups like Novartis' Sandoz unit, which just this week predicted incredible growth for its own biosimilars business. That said, it’s hard to say whether this retrenchment will be part of the long-term learning process or bigger strategic shift, as the whole field is in the midst of an evolution and successful business models have yet to fully materialize.