Merck lays groundwork for biosimilar push
- As biosimilars gain traction in the U.S., Merck is stepping up its educational efforts to help inform patients, physicians and payers for how biosimilars are distinguished from their reference biologic drugs.
- Last week, Merck launched a new website, merckclarifiesbiosimilars.com, as part of its marketing and awareness push. Users self identify as a patient, doctor or payer and can access information on a range of topics tied to biosimilars prepared by Merck.
- Merck has partnered with Samsung Bioepis to commercialize biosimilar versions of a number of top-selling biologics, including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab) and Herceptin (trastuzumab), in certain areas.
While still small, the biosimilar market in the U.S. is growing rapidly. The Food and Drug Administration recently approved Novartis' Erelzi and Amgen's Amjevita, biosimilar versions of Enbrel and Humira, respectively. With those approvals, there are now four biosimilar drugs okayed for use in the U.S.
And just this week, Pfizer announced it would begin selling its Remicade biosimilar Inflectra in November, despite ongoing legal proceedings with Johnson & Johnson over patent rights. So far only Novartis' Zarxio, a biosimilar of Neupogen (filgrastim), has been sold in the U.S. as legal issues have delayed entry of the other two drugs.
Under the partnership with Samsung Bioepis, Merck is responsible for all commercialization activities while the Korean drugmaker handles the preclinical, clinical, manufacturing and registration work for the biosimilar drugs. Earlier this year, the FDA accepted Samsung Bioepis Biologics License Application for its Remicade biosimilar, the first application filed as part of the partnership with Merck.
Bioepis, a Korean joint venture launched by Samsung Biologics and Biogen, also has a partnership in place with Biogen, mostly covering Europe. Biosimilar versions of Remicade and Enbrel developed by Bioepis have already been approved in the E.U., where they are marketed by Biogen.
Merck, on the other hand, mostly has rights to market the biosimilar candidates in the U.S. and other ex-U.S. geographies.
With several other candidates in the pipeline with Bioepis, Merck is using education to pave the way and boost acceptance of the copycat biologics.
Follow Ned Pagliarulo on Twitter