On 9 December 2021, Prestige BioPharma and Dr Reddy’s announced a partnership to commercialize Prestige’s trastuzumab biosimilar, HD201. Trastuzumab (Herceptin, Roche) is a monoclonal antibody against human epidermal growth factor receptor 2 (HER2) and can be used in the treatment of breast and gastric cancers that are positive for the receptor.

Under the partnership, Dr Reddy’s will have exclusive rights for the supply and commercialization of HD201 in select countries in Latin America and Southeast Asia, while Prestige BioPharma will be responsible for commercial supply of the drug from its manufacturing site in South Korea.

Lisa S Park, CEO of Prestige BioPharma, said they are delighted about the partnership, adding: ‘Dr Reddy’s is the ideal partner to commercialize our lead biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets’.

MV Ramana, CEO – Branded Markets (India and Emerging Markets) at Dr Reddy’s, added: ‘[…] Our partnership with Prestige BioPharma will help us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition in these markets. This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets’.

In related news, on 14 December 2021 it was announced that Formycon had entered into an exclusive partnership with MS Pharma for the commercialization of Formycon’s ranibizumab biosimilar, currently known as FYB201.

Under the agreement, MS Pharma will commercialize FYB201 in the Middle East and North Africa (the MENA region) via Bioeq, the licensee and exclusive holder of worldwide commercialization rights for FYB201.

FYB201 is to rival Lucentis, the ranibizumab originator produced by Genentech/Roche. A monoclonal antibody against vascular endothelial growth factor A (VEGF-A), ranibizumab can be used for the treatment of age-related macular degeneration, which can cause blindness. Marketing authorization applications for FYB201 were submitted to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in 2021 [1, 2].

Chief Financial Officer of Formycon AG, Dr Nicolas Combé, commented on the partnership: ‘MS Pharma is a strong partner for the very dynamically developing [MENA] region. We are very excited about this additional commercialization partnership, which further increases the economic potential for FYB201’.

In the US, Coherus BioSciences, Inc is responsible for distribution of FYB201, according to a licensing and development agreement in place since 2019. Teva Pharmaceuticals Ltd is responsible for commercialization in Europe, thanks to an exclusive strategic partnership announced in June 2021 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/biosimilars/news/Formycon-Bioeq-submit-European-marketing-authorization-for-ranibizumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Bioeq submits application for ranibizumab biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/biosimilars/news/Bioeq-submits-application-for-ranibizumab-biosimilar-to-FDA
3. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/pharma-news/Teva-signs-deal-with-Bioeq-for-ranibizumab-biosimilar-FYB201

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