Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal

In May 2022, Biocon Biologics launched a bevacizumab biosimilar co-developed with Viatris (formerly Mylan), in Canada; and in April 2022, Biocon was awarded a three-year contract, worth US$90 million, by Malaysia's Ministry of Health

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.

Canada approves rituximab biosimilar Riabni

Mylan and Biocon submit trastuzumab biosimilar to FDA

Mylan and Biocon submit insulin glargine biosimilar to EMA

Biosimilars approved in Canada

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

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Nomenclature of biologicals and biosimilars in Peru Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Nomenclature of biologicals and biosimilars in Peru !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.