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FDA tentatively approves pemetrexed generic Posted 24/11/2017

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).

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].

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References
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

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Source: Eagle, EMA

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