Second Biosimilar to Infliximab Approved

The Center for Biosimilars Staff

The FDA has granted approval to a second biosimilar to infliximab (Remicade, Johnson & Johnson). Infliximab-abda (Renflexis), an intravenous infusion developed by Samsung Bioepsis/Merck, has been approved for multiple indications.

This tumor necrosis factor (TNF) inhibitor has been indicated for various inflammatory conditions, including Crohn’s disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis (combined with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

"Once Renflexis hits the market, it will be the first time we will see competition between 2 biosimilars, Inflectra and Renflexis, along with the reference product Remicade," said Brian Lehman, MBA, MHA, RPh, who is a manager of pharmacy benefits and policy in Columbus, Ohio. Lehman, who also serves on the editorial board of The Center for Biosimilars, added that Renflexis offers another important option for patients and providers in the treatment of serious inflammatory diseases.

The most common adverse reactions for infliximab-abda include infections, infusion-related reactions, headache, and abdominal pain, and its use is contraindicated with anakinra or abatacept. The label also indicates that the drug has not been evaluated in children under 6 years diagnosed with ulcerative colitis or Crohn’s disease.

Infliximab-abda will be available in single-dose vials containing 100 mg of lyophilized drug for a final reconstitution volume of 10 mL.

The first biosimilar to infliximab, infliximab-dyyb (Inflectra, Pfizer), was approved in November 2016. While Pfizer struggled for a while falling the launch of the drug, the company’s biosimilar revenues grew by 48% a year later—fourth quarter sales from Inflectra touched $61 million in 2016 (up from $30 million a year ago) despite the fact that the drug is being sold at only a 15% discount to Remicade.