Sandoz, Samsung Bioepis Win FDA Nod for Stelara Biosimilar

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. This tracker monitors the regulatory progress of current market products, focusing on their expansion into new geographies and indications.

As of Monday, July 1, several significant developments have occurred:

Sandoz and Samsung Bioepis have achieved FDA approval for Pyzchiva, a biosimilar to Johnson & Johnson's Stelara. The biosimilar has been provisionally endorsed as an interchangeable product by the FDA. This endorsement allows it to be substituted at the pharmacy without a doctor's approval in certain cases. Sandoz will market Pyzchiva in the U.S. under a partnership agreement with Samsung Bioepis. The product is expected to hit the market in February of next year, following a settlement with Johnson & Johnson in November. Pyzchiva is approved to treat plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults. For pediatric patients, it is approved for moderate to severe plaque psoriasis and active psoriatic arthritis.

In another biosimilar breakthrough, Formycon received FDA approval for Ahzantive, a biosimilar to Regeneron's blockbuster Eylea. Ahzantive joins Formycon's Lucentis biosimilar in its portfolio of approved therapies. The FDA has approved Ahzantive for the treatment of wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. Formycon has not yet disclosed its launch plans for Ahzantive.

Additionally, the European Commission has greenlit Valneva's Ixchiq as a single-dose vaccine against the chikungunya virus. Ixchiq is the first chikungunya vaccine globally, having already received approvals in the U.S. and Canada. Valneva is also pursuing regulatory reviews in the U.K. and Brazil. According to Valneva’s chief medical officer, Juan Carlos Jaramillo, M.D., climate change has led to the spread of the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to previously unaffected areas in Europe. Jaramillo emphasized the importance of offering a vaccine not only to European travelers visiting endemic areas in South America or Africa but also to local populations in Europe experiencing increased mosquito activity.

These updates highlight significant strides in the pharmaceutical industry, especially in the development and approval of biosimilars and vaccines. The approval of Pyzchiva and Ahzantive offers patients more treatment options and contributes to the competitive landscape of biosimilars. Meanwhile, the introduction of Ixchiq addresses a growing public health concern related to mosquito-borne diseases, particularly in light of the changing climate.

This tracker will continue to provide updates on the regulatory progress of in-market drugs, including their expansion into new geographies and indications.