Merck launches Renflexis as biosimilar with FDA consent

Renflexis is a tumor necrosis factor (TNF) blocker and is indicated for the treatment of several digestive and autoimmune disorders.
Renflexis is a tumor necrosis factor (TNF) blocker and is indicated for the treatment of several digestive and autoimmune disorders. | File photo

New Jersey-based Merck recently introduced Renflexis (infliximab-abda) in the United States as a biosimilar of Remicade (infliximab) following its FDA approval last April for all eligible indications.

“Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians and payers,” Merck Biosimilars General Manager Dora Bibila said. “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 is a tumor necrosis factor (TNF) blocker and is indicated for the treatment of several digestive and autoimmune disorders including Crohn’s disease (adult and pediatric), ulcerative colitis; rheumatoid and psoriatic arthritis; ankylosing spondylitis and plaque psoriasis

Because side effects of the medication can be serious, the company plans extensive educational and support resources to accompany the release, including information for practitioners, patients and caregivers. Patients treated with infliximab may be at higher risk for infections.

The anticipated list price for wholesaler acquisition of the medication is $753.39. Merck indicated that the figure is equivalent to 35 percent less than Remicade’s cost. Merck collaborated with Samsung Bioepis on the development and marketing of this medication beginning in 2013.

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