Merck launches Remicade biosimilar for all eligible indications, in the US

The biosimilar's list price will represent a 35% discount to the current list price of Remicade.

Merck (MSD) has announced the US launch of Renflexis (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab). Renflexis, which was approved by the FDA on 21 April for all eligible indications, is the first medicine available in the US under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis.

"Merck looks forward to launching Renflexis in the US to help meet the needs of patients, physicians and payers," said Dora Bibila, general manager, Merck Biosimilars. "As a global healthcare leader, Merck believes that biosimilars have the potential to help increase access to these important medicines while also providing savings for the health care system."

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. Wholesaler acquisition costs do not include discounts that may be paid on the products.

The FDA approval of Renflexis (infliximab-abda) was based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical and clinical pharmacokinetic, safety and effectiveness data demonstrating that Renflexis is highly similar to its reference product Remicade, in terms of the safety, purity and potency of the product.