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Biocon to commercialize biosimilars in 31 European countries

Home/Pharma News | Posted 23/01/2024 0 Post your comment

Biocon Biologics has successfully integrated Viatris’ biosimilars business in 31 European countries, it was announced in late November 2023.

Biocon Biologics and Viatris underwent a merger in 2022 [1, 2], whereby Biocon acquired Viatris. Following this, Viatris’ biosimilars business has been integrated in over 70 emerging market countries in July 2023 and in North America in September 2023,

In Europe, Biocon Biologics’ portfolio comprises eight biosimilars: adalimumab, aflibercept, bevacizumab, etanercept, insulin aspart, insulin glargine, pegfilgrastim, and trastuzumab [3]. Table 1 lists the details of the Biocon biosimilars that have been approved in Europe. The latest addition to the portfolio is the aflibercept biosimilar Yesafili, which received approval from the European Commission in September 2023 [4].

Table 1: Biocon biosimilars approved in Europe
Product name	Active substance	Therapeutic area	Authorization date	Manufacturer/ Company name
Julia	adalimumab	Ankylosing spondylitis Crohn’s fisease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis	17 Sep 2018	Mylan/Fujifilm Kyowa Kirin Biologics
Yesafili	aflibercept	Degenerative diabetes complications Diabetic retinopathy myopia Macular oedema Retinal vein occlusion	15 Sep 2023	Biocon/Viatris (formerly Mylan)
Abevmy	bevacizumab	Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer	21 Apr 2021	Mylan (now Viatris)
Nepexto	etanercept	Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Spondylarthropathies	25 May 2020	Mylan (now Viatris)
Kirsty (previously Kixelle)	insulin aspart	Diabetes mellitus	5 February 2021	Biocon/Viatris (formerly Mylan)
Semglee	insulin glargine	Diabetes mellitus	28 Mar 2018	Biocon/Viatris (formerly Mylan)
Fulphila	pegfilgrastim	Neutropenia	20 Nov 2018	Mylan (now Viatris)
Ogivri	trastuzumab	Early breast cancer Metastatic breast cancer Metastatic gastric cancer	12 Dec 2018	Biocon/Mylan
Updated on 23 January 2024

Biocon Biologics and its partners will commercialise the biosimilar products in the following countries: Albania, Austria, Belgium, Bosnia, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the UK.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: ‘The integration of the Viatris’ biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilars leader. We are pleased to expand access to life-saving treatments for patients across Europe. Our unique, fully integrated capabilities and robust pipeline of 20 products will allow us to better address patient needs and be a reliable partner to health organisations.’

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biocon to acquire biosimilars business from Viatris [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 23]. Available from: www.gabionline.net/pharma-news/biocon-to-acquire-biosimilars-business-from-viatris
2. GaBI Online - Generics and Biosimilars Initiative. Biocon–Viatris merger expected [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 23]. Available from: www.gabionline.net/pharma-news/biocon-viatris-merger-expected
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 23]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
4. 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 Jan 23]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars

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