After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara

The FDA has signed off on Amgen’s biosimilar version of Johnson & Johnson’s autoimmune standout Stelara. But don’t hold your breath waiting for the California biotech to launch its new product.

In May, under the terms of a settlement between the companies, Amgen agreed to delay the launch of its copycat in exchange for J&J dropping a patent infringement lawsuit. The deal keeps Wezlana (ustekinumab-auub) off the market until no later than Jan. 1, 2025.

The agreement also makes it likely that Wezlana will become the first Stelara biosimilar to launch in the U.S. In June, J&J made a similar settlement with Alvotech and Teva to delay the launch of their biosimilar version of Stelara, which has yet to gain FDA approval, to no later than Feb. 21, 2025.

The dates are marked in red on the J&J calendar. Last year, Stelara was the company’s top selling product, generating $9.7 billion, which accounted for 10% of J&J’s revenue. Stelara reached the market in 2009. It is approved to treat adults with ulcerative colitis and Crohn’s disease and for those age 6 and older with plaque psoriasis and psoriatic arthritis.

Other companies developing Stelara biosimilars include Samsung Bioepis, Celltrion, Biocon and a partnership between Bio-Thera Solutions and Hikma Pharmaceuticals.

Amgen’s biosimilar approval has an added advantage as it has captured an interchangeable designation, which allows a pharmacist to freely substitute it for Stelara, instead of a healthcare professional signing off on the switch.

To gain interchangeable status, a company must show through a switching study that its biosimilar has no clinically meaningful differences to the reference product in safety, potency and purity.

Earlier this year, Amgen made a high-profile biosimilar launch when it became the first company in the U.S. to hit the market with a copycat version of AbbVie’s autoimmune superstar Humira. With the launch of interchangeable Amjevita, Amgen got a six-month head start on a wave of other companies bringing their Humira biosimilars to the market.

So far this year, Amgen's Amjevita has generated $466 million.

While several biopharma giants have divested their biosimilar and generics units, Amgen has rejected the trend. In its quarterly report on Tuesday, the company said that the FDA had accepted its application to approve its biosimilar version of Regeneron and Bayer’s macular degeneration drug Eylea.

Amgen also said it had increased its investment in developing its biosimilar version of Bristol Myers Squibb’s cancer drug Opdivo.