UPDATE : Friday, July 10, 2020
FDA approves Pfizer’s Remicade biosimilar
  • By Lee Han-soo
  • Published 2017.12.14 17:16
  • Updated 2017.12.14 17:16
  • comments 0

Pfizer said Wednesday that it received U.S. Food and Drug Administration’s (FDA) approval for Ixifi, the company’s biosimilar version of Remicade.

The original Remicade, made by Johnson & Johnson, treats Crohn’s disease, adult ulcerative colitis, ankylosing spondylitis, adult plaque psoriasis, psoriatic arthritis and rheumatic arthritis. It is the fifth best-selling drug worldwide with an annual global sale of $6.7 billion last year.

The FDA approved Ixifi based on the totality of evidence demonstrating a high degree of similarity to Remicade.

The company plans to market the product globally, except for the European Economic Area (EEA), which consists of 28 EU member states and three of the four member states of the European Free Trade Association -- Iceland, Liechtenstein, and Norway. Pfizer sold the rights for the development, commercialization, and manufacture of Ixifi for EEA members to Sandoz, a German pharmaceutical company last year.

However, after Pfizer released its statement, concerns mounted that Pfizer’s new biosimilar might affect the sales of Celltrion's Inflectra, a Remicade biosimilar marketed by Pfizer in the U.S. and certain other markets across the globe.

In response to the growing concerns, Pfizer reaffirmed its commitment toward Inflectra.

“As part of its global biosimilar strategy, Pfizer supplies Celltrion’s Inflectra in the U.S. and some other markets in the world,” Pfizer said in its statement regarding the FDA approval for Ixifi.

Pfizer also reaffirmed its commitment toward Inflectra in a separate letter to Celltrion.

“The company remains in partnership with Celltrion and is committed to commercializing Inflectra in the U.S. and certain other markets, to make it available for patients and physicians in its approved indications,” the company said in an e-mail to Celltrion. “Inflectra is approved in the U.S. for all eligible indications of Remicade, including the treatment of rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.”

Celltrion made a similar response highlighting the strong partnership with Pfizer.

“The partnership between Celltrion and Celltrion Healthcare, and Pfizer continues to be firm,” Celltrion said in a statement. “The sales of Inflectra in the U.S. are also proceeding smoothly.”

The company will continue to do its best to expand sales of Inflectra in the U.S. market, it added.


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