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EMA approval for pegfilgrastim biosimilar Grasustek Posted 10/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.

Grasustek is a biosimilar of Amgen’s Neulasta (pegfilgrastim), which is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [1].

Grasustek was developed by Indian biosimilars maker USV. The application for approval of the biosimilar was submitted to EMA in December 2017 by USV subsidiary Juta Pharma, a German-based generics maker that USV acquired in March 2018.

EMA’s approval for Grasustek was based on data from phase I and phase III studies carried out in Europe. The phase I study compared the pharmacokinetics and pharmacodynamics of the biosimilar with the originator biological Neulasta at both a therapeutic dose and a low dose. The phase III study followed 254 patients with breast cancer who were scheduled to undergo chemotherapy.

USV is also planning a phase I study in the US and has already held a pre-IND meeting with the US Food and Drug Administration. The company has also completed a phase III study in India.

EMA’s CHMP has recommended that Grasustek be approved for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.

The CHMP’s opinion will now be reviewed by the European Commission (EC). There are already five pegfilgrastim biosimilars (Fulphila, Pelgraz, Pelmeg, Udenyca and Ziextenzo) approved in the European Union [2].

Related article
Biosimilars of pegfilgrastim

1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiativ Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EMA, USV

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