Amgen Contests J&J’s Stelara with FDA Approval for Interchangeable Biosimilar
Pictured: Amgen signage outside its headquarters in California/iStock, JHVEPhoto
The FDA on Tuesday approved Amgen’s Wezlana (ustekinumab-auub) for multiple inflammatory diseases, an interchangeable biosimilar to Johnson & Johnson’s blockbuster antibody Stelara (ustekinumab), which could potentially impact the ongoing Medicare drug price negotiations.
Tuesday’s regulatory victory for Wezlana comes as J&J is preparing to face the federal government’s drug price negotiation program for Stelara. Under the Inflation Reduction Act, which President Joe Biden signed into law in August 2022, the Centers for Medicare and Medicaid Services (CMS) will be able to renegotiate prices for some of the most widely prescribed medications.
In August 2023, CMS released the list of the first 10 prescription medicines that will be affected by the negotiation program, including three J&J products: Stelara, the blood thinner Xarelto (rivaroxaban) and blood cancer treatment Imbruvica (ibrutinib). Amgen’s psoriasis therapy Enbrel (etanercept) will also have to face drug price negotiations.
In choosing these products, CMS focused on medicines that had the highest total Part D gross coverage, paying particular attention to those without generic or biosimilar competition. However, according to the agency’s guidelines, medicines can be dropped from the negotiation program if there is “meaningful competition.”
Nonetheless, it is still unclear if Wezlana’s approval on Tuesday would constitute “meaningful competition” for Stelara, and whether this is enough to exempt J&J’s biologic from CMS negotiations.
Like its reference product, Wezlana is also indicated for the treatment of several inflammatory diseases in adults, such as moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis. The biosimilar can also be used in children aged six years and above with active psoriatic arthritis and moderate to severe plaque psoriasis.
Wezlana also shares Stelara’s safety profile. Its label lists infection as its most serious side effect and recommends discontinuing treatment in case of serious or clinically significant infections. Wezlana, like other ustekinumab products, also carries the risk of malignancies, hypersensitivity reactions and non-infectious pneumonia.
“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” Nikolay Nikolov, director of the Office of Immunology and Inflammation at the FDA’s Center for Drug Evaluation and Research, said in a statement.
A biosimilar is a medicine that is highly similar and demonstrates no clinically meaningful difference to a reference biologic product that has already won the FDA’s approval. According to a recent study published in June 2023 in the journal Health Affairs, biosimilars can promote healthy market competition and alter doctors’ prescribing behaviors, thereby helping reduce overall medication costs for patients.
Wezlana has additionally won the FDA’s interchangeability designation, which allows pharmacies to substitute it for the branded counterpart without consulting the prescriber or changing prescriptions.
“This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement.