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FDA Approves a Remicade Biosimilar, But Pfizer Won’t Market It
The FDA has approved infliximab-qbtx (Ixifi, Pfizer), the third biosimilar to Remicade (Johnson and Johnson)––and the second one from Pfizer, which already markets Inflectra in the U.S.
Pfizer and Celltrion Inc. launched Inflectra in late 2016. The other Remicade biosimilar, Renflexis, is made by Merck & Co. and Samsung Bioepis Co. Ltd.
Pfizer acquired Inflectra when it bought Hospira in 2015. At the time, the drugmaker elected not to discontinue development of Ixifi, which was already under way. But the company has no plans to commercialize Ixifi, Pfizer told Reuters. “We are currently evaluating our strategic options for Ixifi. But we are continuing to commercialize Inflectra in the U.S.,” a Pfizer spokesman said.
The chimeric human-murine monoclonal antibody against tumor necrosis factor was approved for all indications of the original: rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The FDA’s approval is based on the totality of evidence demonstrating a high degree of similarity to the reference product, including the REFLECTIONS B537-02 study in patients with moderate to severe active rheumatoid arthritis (RA). The phase 3, multinational, randomized, double blind, two-arm, parallel group study evaluated the safety, efficacy, and immunogenicity of Ixifi versus Remicade administered intravenously in combination with methotrexate to treat patients with moderate to severely active RA who have had an inadequate response to methotrexate therapy.
The study met its primary endpoint of ACR20 response (at least a 20% improvement by American College of Rheumatology criteria) at week 14, and was supported by data at week 30.
Remicade is Johnson & Johnson’s bestselling drug and raked in revenues of $1.65 billion in the latest quarter.