Source – Johnson & Johnson
By early 2025, a new settlement may allow for the entry of a second biosimilar medicine that imitates Johnson & Johnson’s best-selling medication Stelara without facing any legal challenges for patent infringement.
Alvotech and Teva have been given a license by J&J to market its envisioned Stelara Biosimilar, AVT04, in the US. According to the businesses, the agreement permits the producers of biosimilars to release their product no later than February 21, 2025.
The latest agreement between J&J and Amgen, which grants the latter company permission to introduce its knockoff no later than January 1, 2025, is followed by the new Stelara Biosimilar agreement.
Alvotech and Teva, like Amgen, have not received FDA approval for AVT04. The couple stated in January that the FDA had approved their application and was expected to make a decision in the second part of this year. By the end of the third quarter, a decision about Amgen’s version is anticipated.
For J&J, settling those Biosimilar entry dates is crucial. Stelara, which accounted for 10% of J&J’s total revenue base in 2022 and had sales of $9.7 billion, has been the pharmaceutical company’s best-selling product. The US contributed almost $6.4 billion to the haul.
A number of inflammatory illnesses, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, are authorized for treatment with the IL-12/23 inhibitor. The US composition of matter patent covering the medication will expire in September.
Along with Samsung Bioepis, Celltrion, Biocon, and a joint venture between Bio-Thera and Hikma, other businesses creating Stelara Biosimilars include Biocon.
