FDA tentatively approves pemetrexed generic

Genéricos/Novedades | Posted 24/11/2017 post-comment0 Post your comment

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).

Alimta V13H23

Eagle’s generic version, which is called Pemfexy, comes as an injectable ready-to-dilute formulation. It has been approved for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic non-squamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic non-squamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.

‘Tentative approval’ means that FDA has concluded that the drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the US because of existing patent protections. Final approval depends on resolution of patent litigation with Eli Lilly. If Eagle secures that approval, the firm expects to capture between a quarter and a third of the market.

Eli Lilly filed the lawsuit in September 2017, arguing that the company infringed on its patents for Alimta, which had US sales of approximately US$1.0 billion over the last 12 months. If the patents are ruled valid, no generics will be available in the US until Eli Lilly’s patent on Alimta expires in May 2022.

In the European Union pemetrexed generics have been approved since 2015 [1]. In addition, in February 2016, the UK High Court ruled that Eli Lilly’s vitamin regimen patent for Alimta (pemetrexed disodium) is not infringed by a generic version of the drug sold by Allergan’s Actavis unit [2].

Related articles
Tentative FDA approval for chemotherapy generic

Teva gains tentative approval for generic atorvastatin

1. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – August 2017 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-August-2017
2. GaBI Online - Generics and Biosimilars Initiative. UK paves way for generics of Eli Lilly’s Alimta [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Generics/News/UK-paves-way-for-generics-of-Eli-Lilly-s-Alimta

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 © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Eagle, EMA

comment icon Comments (0)
Post your comment
Related content
Sandoz launches ferumoxytol and pemetrexed generics
88 MD002468
Genéricos/Novedades Posted 03/09/2021
US generic approvals for Acrux and Cipla
31 MD000575
Genéricos/Novedades Posted 16/07/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010