EC approval for pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 15/01/2021 post-comment0 Post your comment

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.

Pegfilgrastim V16B19

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 [1]. The patents on Neulasta expired in the US in October 2015 and in Europe in August 2017 [2].

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 [3].

Pfizer has also received European approval for biosimilars of adalimumab (Amsparity), filgrastim (Nivestim), rituximab (Ruxience), trastuzumab (Trazimera) and bevacizumab (Zirabev) [4].

The company intends to make Nyvepria available to patients in several European countries starting in Q1 2021.

Related article
Biosimilars of pegfilgrastim

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

 

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim 
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

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.

Source: ClinicalTrials.gov, EMA, Pfizer

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010