Merck & Co. Fine-Tunes Biosimilars Strategy as FDA Guidelines Loom

(Ref: Xconomy)
  • Michael Kamarck, president of Merck & Co.'s unit focused on biosimilars, said that the company doesn't "know exactly what {FDA] guidelines will say" when they are released, although he added "we are confident we have a path to move forward and we can succeed," Xconomy reported Wednesday.
  • The US regulator is thought to soon announce guidelines for approving biosimilars, which are expected to mean that drugmakers such as Merck will have to jump through many more hoops than makers of "small-molecule," chemical-based generic drugs do.
  • "All they have to do is the chemical analysis to show it’s the same drug," Kamarck noted, adding that producers of biosimilars "will have to do some amount of clinical study to prove safety and efficacy."
  • Merck is targeting to have five or more biosimilars in the pipeline, with some ready to launch in 2016, when patents on the originals are set to expire. "To hit that business target, we looked at areas where we had gaps, and we went out to close them," Kamarck remarked.
  • As part of its strategy, the company bought Insmed, acquiring rights to biosimilar versions of Amgen's Neupogen (filgrastim) and Neulasta (pegfilgrastim), and also signed a deal this year with Hanwha Chemical to develop and commercialise its version of Amgen and Pfizer's Enbrel (etanercept).
  • Kamarck expects that regulatory requirements will differ for each molecule, depending on its complexity, but that overall the FDA will allow for the process to be a shortened version of what it requires for entirely new drugs.