Merck announces launch of Renflexis (Remicade biosimilar) in the United States

Merck announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab).

Renflexis was approved by the U.S. Food and Drug Administration (FDA) on April 21 for all eligible indications. Renflexis is the first medicine available in the U.S. under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis Co., Ltd.

“Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians and payers,” said Dora Bibila, general manager, Merck Biosimilars. “As a global health care 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 U.S. at a list price (wholesaler acquisition cost) of $753.39, representing a 35 percent 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.

Serious and sometimes fatal side effects have been reported with infliximab products. Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma (HSTCL), and other malignancies have been reported, including in children and young adult patients. Due to the risk of HSTCL, mostly reported in Crohn’s disease and ulcerative colitis, assess the risk/benefit, especially if the patient is male and is receiving azathioprine or 6-mercaptopurine treatment. Renflexis is contraindicated in patients with severe hypersensitivity reactions to infliximab products and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome.

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

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.