Prestige Biopharma (Prestige) and Intas Pharmaceuticals have entered a partnership to supply and commercialize Prestige Biopharma’s bevacizumab biosimilar in a number of countries globally. In addition, Samsung Bioepis has partnered with Samil to market their Lucentis (ranibizumab) biosimilar for ophthalmic diseases in South Korea.
Prestige-Intas (Accord) partnership
Under the terms of the new agreement, Prestige’s bevacizumab biosimilar will be supplied and commercialized by Intas and its affiliate Accord Healthcare in the US, Europe, Canada, Middle East and North Africa (MENA), Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan. This partnership was announced in July 2022.
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [1]. The originator is Roche’s Avastin, whose patents expired in the US in 2019 and in Europe in 2022 [2]. Prestige bevacizumab is currently finalizing stage III clinical trials, following the success of phase I trials, before it files for approval in the US and EU [3].
It is hoped that the partnership improves access to bevacizumab, by providing the product at a more affordable price to the originator, whose sales grossed over US$6 billion in 2021, according to IQVIA.
Samsung Bioepis-Samil partnership
Samsung Bioepis and Samil are partnering in South Korea to commercialize Amelivu, a ranibizumab biosimilar for ophthalmic diseases. This partnership was announced in June 2022.
The biosimilar developed by Samsung Bioepis references Genentech’s Lucentis (commercialized by Roche and Novartis) is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor alpha (VEGF-A), a mechanism similar to bevacizumab [4, 5].
Ranibizumab can be used to treat macular degeneration as it inhibits VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The originator is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [4].
Samsung Bioepis’ ophthalmology biosimilar was approved in the US in September 2021 [6, 7], Europe in August 2021 [8, 9] and South Korea [10]. In the US, it is marketed as Byooviz (ranibizumab-nuna) and is approved for the treatment of neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV) [7].
It has not yet been announced when the product will launch in South Korea as Samsung Bioepis reached a patent-related agreement with Genentech in 2021. Under the agreement Samsung Bioepis can only sell the product outside the US after Genentech’s supplementary protection certificate for Lucentis expires and the date of this has not been revealed.
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References
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2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Phase III trials started for bevacizumab and natalizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/news/Phase-III-trials-started-for-bevacizumab-and-natalizumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/research/phase-iii-trial-evidence-used-in-approval-of-ranibizumab-biosimilar-byooviz
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
9. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Samsung Bioepis Biogen’s ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
10. GaBI Online - Generics and Biosimilars Initiative. Lucentis biosimilars approved in the UK and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/news/lucentis-biosimilars-approved-in-the-uk-and-korea
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