FDA Postpones Advisory Meeting on Biosimilar Copy of Remicade

The US Food and Drug Administration (FDA) has postponed an advisory committee meeting to consider approval of Hospira and partner Celltrion’s biosimilar of Remicade.

The agency said that it wants more time to review the Biologics License Application (BLA) for CT-P13, a proposed biosimilar to Janssen Biotech Inc.’s Remicade (infliximab), submitted by Celltrion, Inc. The FDA’s Arthritis Advisory Committee was originally scheduled to meet on March 17, 2015 to discuss the biosimilar’s use in patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The agency said that the reason the meeting is being postponed is “due to information requests pending with the sponsor of the application.”

Celltrion and Hospira have filed for approval of Remsima in the US as a biosimilar version of Janssen’s Remicade, which brings in roughly $8.4 billion annually worldwide. Biosimilar versions of the drug have already been launched in other markets. This week, the companies launched biosimilar versions of Remicade in 12 major European markets.

The advisory panel hearing is a major milestone in advancing new drugs. A positive recommendation would pave the way for the FDA to approve the drug, allowing the companies to start marketing Remsima in the US. The FDA did not say when the committee will meet, but said that a future meeting date will be announced in the Federal Register.

Biosimilars have yet to enter the US market, however several companies are developing cheaper versions of biologic drugs. The FDA is expected to make a decision on whether to approve Novartis’ biosimilar version of Amgen’s blockbuster Neupogen. Additionally, Sandoz is working on copycats of Humira, Enbrel, Rituxan and Procrit. Apotex also has a version of Amgen’s Neupogen under review.

Additionally, Pfizer agreed to buy Hospira for about $15 billion, gaining access to its pipeline of biosimilars.

Source: US Food and Drug Administration

Check Also

FDA Approves Gavreto for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: …

Leave a Reply

Your email address will not be published. Required fields are marked *