Top five articles on biosimilars include nods to FDA approval

The most highly accessed articles about biosimilars on Healio.com/Rheumatology have largely focused on the reaction to the FDA approval of the first biosimilar to infliximab in the United States.

However, news from Europe about biosimilars has also garnered interest.

FDA approves biosimilar to infliximab

The FDA has approved Celltrion’s infliximab-dyyb, a biosimilar to infliximab, for multiple indications, including rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease in adults and children older than 6 years, and patients with moderate to severe ulcerative colitis who inadequately responded to conventional treatment. Read more.

Prime Therapeutics encourages regulators to finalize biosimilar standards

Following FDA approval of Celltrion’s biosimilar to Janssen’s infliximab, Prime Therapeutics LLC issued a statement noting it remains “cautiously optimistic” about the future of biosimilar agents in the United States and urged regulators to finalize decisions on their use. Read more.

American College of Rheumatology responds to FDA approval of biosimilar to infliximab

Earlier this week, the FDA approved Celltrion’s infliximab-dyyb — a biosimilar to infliximab — for multiple indications, including rheumatoid arthritis and psoriatic arthritis. Read more.

Flixabi biosimilar to infliximab gains positive CHMP opinion

The Committee for Medicinal Products for Human Use has issued a positive opinion for the marketing authorization of Flixabi, formerly known as SB2, a biosimilar to infliximab. The biosimilar is developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics. Read more.

FDA issues draft guidance for labeling of biosimilars

The FDA has issued a new draft guidance which recommends biosimilar labeling that differentiates biosimilar products from their reference drugs. Read more.