In January 2024, Regeneron filed a lawsuit against Amgen in the federal court in Los Angeles, alleging Amgen's proposed biosimilar of Regeneron's Eylea (aflibercept) violates patent rights. Additionally, in February 2024, Iceland-based Alvotech announced the anticipated global market entry dates for AVT04, a ustekinumab biosimilar to Stelara, following its settlement with Johnson & Johnson.
Regeneron lawsuit
Regeneron sued Amgen in the federal court in Los Angeles, alleging that Amgen's proposed aflibercept biosimilar of ophthalmic biological, Eylea, would infringe 32 patents covering the originator’s manufacture and use. Eylea earned Regeneron US$6.26 billion in US sales in 2022.
Regeneron has filed similar lawsuits against other biotech companies seeking to make Eylea biosimilars. In December 2023, a federal judge in West Virginia determined that Viatris' proposed biosimilar violated a patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. The patent is expected to expire in June 2027 in the US [1].
Aflibercept is a VEGF inhibitor, a recombinant fusion protein consisting of human VEGF receptor 1 and VEGF receptor 2 extracellular domains fused to the Fc portion of human IgG1 which acts as a soluble decoy for the natural VEGF receptors that inhibits their activation, thereby reducing pathological angiogenesis [2].
Alvotech vs Johnson & Johnson
In the US in June 2023, Johnson & Johnson, the maker of Stelara (ustekinumab), settled a lawsuit against Alvotech and Teva Pharmaceuticals. This was regarding the proposed ustekinumab biosimilar for the treatment of autoimmune conditions [3]. This settlement granted a license entry date for the biosimilar (AVT04) in the US no later than 21 February 2025.
Now, Alvotech announced that the latest agreement with Johnson & Johnson involves Canada, the European Economic Area, and Japan. Alvotech said that AVT04 is expected to enter the Canadian market sometime in the first quarter of 2024. The Japanese launch is estimated to start in May 2024. In Europe, Alvotech expects to enter ‘as soon as possible’ after the European Supplementary Protection Certificate expiration date for the drug, which runs out in July 2024.
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [4].
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 22]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
3. GaBI Online - Generics and Biosimilars Initiative. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 22]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
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