FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar

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FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar

Biosimilares/Novedades | Posted 28/01/2022 0 Post your comment

The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].

Eli Lilly’s Rezvoglar is the second insulin glargine biosimilar to be approved in the US. The first insulin glargine biosimilar, Semglee, was approved in June 2020 [2] and was the first biosimilars to be given interchangeable status in July 2021 [3].

Rezvoglar is a long-acting human insulin analogue indicated to improve glycaemic control in adults and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is a proposed biosimilar to Sanofi’s Lantus (insulin glargine), which generated an estimated US$6.4 billion in net sales income globally for Sanofi in 2015, before the advent of biosimilars [4]. The patents on Lantus expired in 2014 in both Europe and the US [5].

Yusimry is produced by Coherus BioSciences. It is a biosimilar to AbbVie’s originator biological Humira (adalimumab), which is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The approval of Yusimry brings the total number of adalimumab biosimilars approved in the US to seven [1]. The adalimumab biosimilar Cyltezo became the second biosimilar to be given interchangeable status in October 2021 [6].

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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 this week’s headline article: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina 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 esta semana: Diferencias en inmunogenicidad, farmacovigilancia y documentos legales en productos biológicos en América Latina 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. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-insulin-glargine
5. 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
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangeable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable

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Source: US FDA