In August 2024, Biocon signed a settlement and license agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson (collectively referred to as ‘Janssen’), which clears the way for the commercialization of its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Canada, Europe, Japan, and the UK. This follows the news that in November 2023, Biocon announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had granted marketing authorization for Yesafili, the company’s biosimilar of Regeneron and Bayer's Eylea (aflibercept). Yesafili also received tentative approval from Health Canada in March 2023.

Ustekinumab settlement and license agreement with Janssen
Biocon has resolved patent disputes with Janssen to secure market entry dates in Canada, Europe, Japan, and the UK for its ustekinumab biosimilar Bmab 1200. Regulatory filings in these markets are currently under review. 

This comes after news of a settlement agreement in the US for a Bmab 1200 launch no later than 22 February 2025, once approved by the US Food and Drug Administration (FDA). FDA has accepted Biocon’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

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 [1]. 

Yesafili (aflibercept) biosimilar: UK authorization and market entry secured in Canada
Biocon’s aflibercept biosimilar, Yesafili, received approval from the UK’s MHRA on 13 November 2023. Yesafili is used to treat:

• Neovascular (wet) age-related macular degeneration
• Macular oedema following retinal vein occlusion
• Diabetic macular oedema
• Diabetic retinopathy

Yesafili received tentative approval from Health Canada in March 2023. It is administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution, following the dosing regimens recommended in the product labelling, to treat the conditions listed above. Yesafili was approved in Europe in September 2023, and Biocon is set to commercialize its biosimilars in 31 European countries [2, 3].

In March 2024, Biocon signed a settlement with Regeneron and Bayer to pave the way for the introduction of Yesafili into the Canadian market. Under the terms of the agreement, Biocon has secured a launch date for the product that will be no later than 1 July 2025. In addition, in May 2024, the FDA approved Biocon’s Yesafili and Samsung Bioepis and Biogen's Opuviz as the first interchangeable biosimilars to Eylea [4].

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [5]. It binds to circulating VEGFs, acting as a ‘VEGF trap’ and thereby inhibits the activity of the VEGF-A and VEGF-B subtypes, as well as to placental growth factor (PGF). This inhibits the growth of new blood vessels in the choriocapillaris or the tumour, respectively. Aflibercept functions as a soluble decoy receptor that binds VEGF-A, VEGF-B, and PGF.

By blocking VEGF, aflibercept helps prevent these blood vessels from growing and leaking, thereby stabilizing or improving vision.

Related articles
FDA approves first interchangeable ustekinumab biosimilar Wezlana

Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from:
www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biocon to commercialize biosimilars in 31 European countries biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from:
www.gabionline.net/pharma-news/biocon-to-commercialize-biosimilars-in-31-european-countries
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from:
 www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-aflibercept-biosimilars-to-treat-macular-degeneration
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept

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