- Merck and Samsung Bioepis have just received regulatory approval from South Korea's Ministry of Food and Drug Safety for Renflexis (infliximab), a biosimilar of Remicade, which is manufactured by Johnson & Johnson and Merck.
- Renflexis won indications in this market for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adult patients (age 18 years and older).
- Merck plans to launch Renflexis in the first half of 2016.
It's only been three months since the Merck/Samsung Bioepsis development team won approval for Brenzys, a biosimilar version of Amgen's psoriasis drug Enbrel (etanercept). The team plans to launch Brenzys in the first half of 2016—roughly around the same time Renflexis should launch.
Merck and Samsung Bioepsis have had a development and commercialization agreement in place for multiple biosimilar drugs since February 2013. This newest approval represents yet another step forward for the partnership. As an indication of the potential market size, the branded Remicade generated about $10 billion in revenues last year. The partnership agreement also stipulates collaboration on biosimilar versions of AbbVie's Humira, Roche/Genentech's Herceptin, and Sanofi's Lantus.
Merck already is a co-partner with J&J on Remicade, but the deal with Bioepsis is aimed at gaining a foothold in the biosimilar marketplace. This goal speaks to the tremendous potential of the global biosimilars market over the next 10 years, especially as the U.S. becomes a bigger part of that market.
Currently the team is in late-stage development of biosimilar Humira (adalimumab).