Sun Pharma and Dr Reddy’s generics progress in EU and US

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Sun Pharma and Dr Reddy’s generics progress in EU and US

Genéricos/Novedades | Posted 05/11/2021 0 Post your comment

October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) meeting of 11–14 October 2021 granted a positive opinion regarding the generic Sitagliptin SUN (sitagliptin fumarate). This Sun Pharmaceutical product is a generic version of Januvia and is an anti-diabetic medication used to treat type 2 diabetes.

In the US, Dr Reddy’s Laboratories obtained Food and Drug Administration (FDA) approval for generic lenalidomide capsules, in 2.5 mg and 20 mg strengths. This is a generic of Celgene’s Revlimid and Dr Reddy’s approved lenalidomide capsules are now eligible for 180 days of generic drug exclusivity. In addition, Dr Reddy’s received tentative approval for the product in 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is used to treat adult patients with multiple myeloma.

This announcement came following a patent litigation between Dr Reddy’s and Celgene, that was settled in September 2020.

EMA recommends approval of Lenalidomide Mylan

Russian court approves first compulsory licence

Alvogen receives European approval for generic lenalidomide

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.

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.