Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara

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来源: FiercePharma

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. (Pixabay)

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024.

On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications.

UPDATED: Monday, July 1 at 8:51 a.m.

Sandoz and Samsung Bioepis' Pyzchiva, a biosimilar to Johnson & Johnson's Stelara, has gained FDA approval.

The agency provisionally endorsed the biosimilar as an interchangeable product, meaning that in some cases it can be substituted at the pharmacy counter without a doctor's permission.

Sandoz will commercialize the biosimilar in the U.S. under the partnership between the companies. The biosimilar is set to reach the market in February of next year thanks to a settlement the partners struck with Johnson & Johnson in November.

Pyzchiva is approved to treat plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults. In pediatric patients, the biosimilar is approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis.

Also on the biosimilar front, Formycon's biosimilar to Regeneron's blockbuster Eylea has gained an FDA nod.

Branded as Ahzantive, the new biosim joins Formycon's Lucentis biosimilar on its roster of approved therapies.

The FDA approved Ahzantive to treat wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion.

Formycon did not detail its launch plans in its approval press release.

The European Commission has approved Valneva's Ixchiq as a single-dose vaccine to protect against chikungunya virus.

Ixchiq is the world's first chikungunya vaccine, having gained prior approvals in the U.S. and Canada. Other regulatory reviews are progressing in the U.K. and Brazil, Valneva said in a press release.

"In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected," Valneva's chief medical officer, Juan Carlos Jaramillo, M.D., said in a statement.

"It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks."

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