Merck & Co. has launched Renflexis (infliximab-abda), a biosimilar of Johnson & Johnson’s (J&J) anti-inflammatory drug, Remicade (infliximab). Remicade is the top-selling drug in J&J’s pharmaceuticals division with 2016 sales of $6.97 billion.

The US Food and Drug Administration approved Renflexis in April 2017 for all eligible indications. Renflexis is a tumor necrosis factor blocker approved for treating Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The drug is available under a global biosimilars development and commercialization agreement between Merck & Co.  and Samsung Bioepis Co., a joint venture between Samsung BioLogics, a contract biologics manufacturer, and Biogen.

Renflexis will be introduced in the US at a list price (wholesaler acquisition cost) of $753.39, representing a 35% discount to the current list price of Remicade, its reference product, according to Merck & Co. Wholesaler acquisition costs do not include discounts that may be paid on the products.

Launch resources will include education and support services for healthcare professionals, patients, and their caregivers, including biosimilars education, disease education, and reimbursement and access support.

Merck & Co. and Samsung Bioepis formed a development and commercialization agreement in February 2013 under which Merck & Co.  will commercialize multiple biosimilar candidates in certain partnered territories. Under the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials, and regulatory registration. Under a separate development and commercialization agreement with Samsung Bioepis announced in February 2014, Merck is responsible for the development, registration, manufacturing, and commercialization of MK-1293 (insulin glargine) worldwide.

Source: Merck & Co. and Samsung Bioepis