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

Generics/News | Posted 05/11/2021 post-comment0 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.

Diabetes V14K06

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.

Related articles
Pfizer sues Aurobindo and Dr Reddy’s over Ibrance (palbociclib) generics

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.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Pfizer and Merck COVID-19 antiviral progress
26 AA011066
Generics/News Posted 12/11/2021
Sandoz launches ferumoxytol and pemetrexed generics
88 MD002468
Generics/News Posted 03/09/2021
US generic approvals for Acrux and Cipla
31 MD000575
Generics/News Posted 16/07/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010