On October 31, 2023, the U.S. Food and Drug Administration approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab), according to a report published on JDSupra.
Janssen’s original drug, Stelara, is an established medication used in the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. The approval of a biosimilar, essentially a biological product that is highly similar to the original product, is of significance for multiple reasons.
Firstly, it offers a new treatment option for patients. As being categorized ‘interchangeable’, it means that the pharmacy could switch the original drug with the biosimilar without consulting the prescribing physician, thereby removing a potential barrier to access for patients.
Secondly, such a development is expected to drive cost efficiencies in the broader healthcare system. The realization of a market for biosimilars is predicted to foster a heightened competition which, in turn, is likely to put a downward pressure on the prices of both the original drug and its biosimilars.
The approval comes after Amgen and Janssen settled their associated Biologics Price Competition and Innovation Act (BPCIA) lawsuit in May 2023. According to the settlement, Amgen was granted permission to launch Wezlana no later than January 1, 2025. However, with the FDA approval now secured, it is expected that they will possibly look to go to market earlier than initially agreed upon.
This development marks a milestone in the U.S. pharmaceutical market and could potentially signify a trend towards numerous other biosimilar products entering the market, bringing both increased choices for patients and enhanced market competition to the industry.