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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