Even though another biosimilar to infliximab (Remicade) was approved by FDA in mid-December, it likely won’t be marketed in the United States.
Pfizer said it will not launch Ixifi (infliximab-qbtx), the biosimilar to Johnson & Johnson’s Remicade in the US, since the drugmaker already sells the biosimilar infliximab-dyyb (Inflectra), Regulatory Focus reported. Remicade and the biosimilar versions treat rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, and other inflammatory conditions.
Ixifi is the Remicade biosimilar that Pfizer developed prior to the company’s acquisition of Hospira in 2015, a Pfizer spokesperson told Regulatory Focus, while Hospira and Celltrion had developed Inflectra. Pfizer opted to market Inflectra in the US and Europe, so Ixifi may be launched in other countries that are not marketing Inflectra.
There is another cog in the wheel that is limiting the marketing of biosimilars to Remicade, which include infliximab-abda (Renflexis, Merck and Samsung). This fall, Pfizer sued Johnson & Johnson over exclusionary contracts that Pfizer said were limiting its ability to gain Remicade market share, Regulatory Focus reported. Remicade still controls 96% of the market.
Meanwhile, FDA approval’s of Ixifi is “based on the totality of evidence demonstrating a high degree of similarity to the reference product,” Pfizer said in a statement, including the Reflections B537-02 study in patients with moderate to severe active RA.
The phase 3, multinational 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 end point of greater than 20% improvement utilizing the American College of Rheumatology criteria at Week 14, and was supported by data at week 30.