Canada deal
Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars and Biocon/Mylan’s Abevmy (MYL 1402O) bevacizumab biosimilar was one of them, which was approved on 5 November 2021 [1].

Biocon Biologics has launched Abevmy (bevacizumab), an oncology biosimilar co-developed with Viatris, in Canada, in May 2022. This is a biosimilar of Roche’s Avastin, a monoclonal antibody that 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 [2]. The drug has already been approved in Europe under the same name [3], and in India under the name Krabeva [4].

Malaysia deal
In Malaysia, Biocon’s Malaysian subsidiary, Biocon Sdn Bhd will be launching a range of insulin formulations: Insugen-R, Insugen-N, and Insugen-30/70. As part of the deal, Biocon Sdn Bhd will manufacture and supply its range of insulins to its Malaysian partner, Duopharma Marketing Sdn Bhd (Duopharma), a subsidiary of Duopharma Biotech. Duopharma will provide distribution services to all Ministry of Health hospitals, district health offices and health clinics. There are an estimated 3.9 million diabetics in Malaysia, and 420,000 patients are treated using human insulin in government hospitals and clinics, so it is hoped that the Duopharma-Biocon partnership will improve diabetes management by providing high quality and cost-effective biosimilar insulins throughout Malaysia. This is the second time that Biocon has won such a deal with Malaysia's Ministry of Health and the previous iteration was granted in 2017.

The insulin formulations are manufactured at Biocon’s Johor facility, the first and only biopharmaceutical sterile injectables facility in Malaysia to receive both United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval. It is part of Biocon’s Centre of Excellence for insulins in Malaysia with end-to-end capabilities to manufacture a broad portfolio of regular, basal, and rapid insulins. The facility is proud to manufacture Biocon's biosimilar insulin glargine, the first biosimilar to receive the interchangeable designation, awarded by FDA [5]. It is also providing affordable access to life-saving insulins to patients in many global markets such as Europe, Australia, the Middle East and Latin America.

Related articles
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Mylan and Biocon submit trastuzumab biosimilar to FDA

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Biosimilars approved in Canada

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

References
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves five biosimilars in last seven months [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www.gabionline.net/biosimilars/news/canada-approves-five-biosimilars-in-last-seven-months
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab and bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www.gabionline.net/biosimilars/news/canada-approves-adalimumab-and-bevacizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EC approves bevacizumab biosimilar Abevmy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www.gabionline.net/biosimilars/news/EC-approves-bevacizumab-biosimilar-Abevmy
4. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www.gabionline.net/biosimilars/news/Bevacizumab-similar-biologic-launched-in-India
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 10]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar

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