The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.
Nyvepria is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2016, before the advent of biosimilars . The patents on Neulasta expired in the US in October 2015 and in Europe in August 2017 .
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. Febrile neutropenia is a common side effect of cancer treatments, such as chemotherapy, which can leave patients vulnerable to infections.
The approval by the EC on 18 November 2020 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation during its meeting, which took place on 14‒17 September 2020. The CHMP recommended at that meeting that Nyvepria be approved for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy. The positive opinion was based on a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nyvepria to its reference product. Data from Pfizer’s open-label phase I/II study characterizing the pharmacodynamics, pharmacokinetics and safety of HSP-130 in women with non-metastatic breast cancer was included in the data package.
Nyvepria (pegfilgrastim-apgf) also received approval in the US in June 2020 .
Pfizer has also received European approval for biosimilars of adalimumab (Amsparity), filgrastim (Nivestim), rituximab (Ruxience), trastuzumab (Trazimera) and bevacizumab (Zirabev) .
The company intends to make Nyvepria available to patients in several European countries starting in Q1 2021.
Biosimilars of pegfilgrastim
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2. Derbyshire M, Shina S. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves pegfilgrastim biosimilar Nyvepria [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-pegfilgrastim-biosimilar-Nyvepria
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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Source: ClinicalTrials.gov, EMA, Pfizer