The US Food and Drug Administration (FDA) has approved the infliximab biosimilar product infliximab-qbtx (Ixifi, Pfizer Inc) for all eligible indications for the US-licensed infliximab reference product ( Remicade, Janssen Biotech Inc), Pfizer has announced.
Infliximab is a tumor necrosis factor blocker. The FDA has already approved two other infliximab biosimilars ― infliximab-abda (Renflexis, Samsung Bioepis) and infliximab-dyyb (Inflectra, Celltrion).
According to the FDA, approval of a biosimilar product is based on a showing that it is highly similar to an already approved biological reference product. Biosimilars must also demonstrate no clinically meaningful differences in safety and effectiveness from the reference product.
The FDA has approved Ixifi as a treatment for patients with rheumatoid arthritis (RA), Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, Pfizer said in a news release.
The FDA approval is based on the “totality of evidence demonstrating a high degree of similarity to the reference product,” the company said, including the REFLECTIONS B537-02 study, which was conducted in patients with moderate to severe active RA.
This phase 3, multinational, randomized, double-blind, two-arm, parallel group study evaluated the safety, efficacy, and immunogenicity of Ixifi in comparison with Remicade administered intravenously in combination with methotrexate to treat patients with moderately to severely active RA who failed to respond adequately to methotrexate.
The study met its primary endpoint of ≥20% improvement by American College of Rheumatology criteria (ACR20) at week 14, and was supported by data at week 30, Pfizer said.
The full prescribing label for Ixifi is available online.
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