The interchangeable insulin glargine biosimilar, Semglee, has been listed by Express Scripts, America’s largest pharmacy benefit management organization, as a preferred insulin brand on its National Preferred Formulary (NPF), which includes more than 28 million lives in the US.
Semglee (insulin glargine-yfgn) was the first biosimilar to be granted interchangeable status by the US Food and Drug Administration (FDA) in July 2021 [1].
The biosimilar is made by US-based drugmaker Viatris (formerly Mylan) and partner, India-based biologicals specialist Biocon. The companies received approval from FDA for their insulin glargine biosimilar Semglee (MYL‑1501D) on 11 June 2020 [2].
Biocon and Viatris say that this decision ‘will help increase access to this critical treatment for millions of Americans living with diabetes’. They add that ‘broad coverage of Semglee by Express Scripts will help ensure that the many patients on its network who need insulin glargine may receive the full benefits of and access to treatment with lower or maintained out-of-pocket costs’.
Viatris commercializes Semglee injection in the US, which Biocon and Viatris call a ‘branded interchangeable biosimilar’, and Insulin Glargine (insulin glargine-yfgn) injection, an authorized interchangeable biosimilar. Both products will be available in pen and vial presentations and are interchangeable for the reference biological, Lantus. In addition, Semglee will also be included in Express Scripts’ Patient Assurance Program.
The companies state that ‘this dual product approach is intended to ensure that this historic interchangeable biosimilar insulin glargine can reach as many patients as possible regardless of financial circumstances, insurance or channel’.
Editor’s comment
Readers interested to learn more about biosimilars and interchangeability are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Interchangeability of biosimilars in the US and around the world
Interchangeability. An insurmountable fifth hurdle?
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
Related article
Interactive map for interchangeable biosimilars
| 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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE 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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE 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. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 5]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
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.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment