FDA approves pegfilgrastim and rituximab biosimilars

Biosimilars/News | Posted 24/06/2022 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).

18794124_l

India-based generics maker Amneal Pharmaceuticals (Amneal) announced on 27 May 2022 that it had received approval from FDA for its pegfilgrastim biosimilar. Fylnetra is a 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].

Fylnetra is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The biosimilar was developed in collaboration with US-based Kashiv Biosciences. It is the third biosimilar from Amneal to receive FDA approval in 2022, following the approval of the filgrastim biosimilar Releuko (filgrastim-ayow) in February 2022 [3] and the bevacizumab biosimilar Alymsys (bevacizumab-maly) in April 2022 [4].

US Pharma Giant Amgen announced on 6 June 2022 that it had received approval from FDA for its rituximab biosimilar. Riabni (ABP 798) is a biosimilar to Roche’s MabThera/Rituxan (rituximab), which had sales of CHF 7.3 billion (Euros 6.4 billion) in 2016, before the advent of biosimilars [5]. The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [2].

Riabni has been approved for use in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor antagonist therapies. Riabni is already approved for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis (also called Wegener's granulomatosis) and microscopic polyangiitis.

The FDA approval of Riabni was based on the review of a comprehensive data package, which included data from a randomized, double-blind, comparative clinical study that compared the efficacy, safety, pharmacokinetics and immunogenicity of Riabni versus rituximab reference product (RP) in patients with moderate to severe RA. Overall, 311 patients were randomized and treated with Riabni, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US). The rituximab-US group transitioned to Riabni in period 2 of the study. The primary efficacy endpoint, the change in disease activity score 28 using C-reactive protein (DAS28-CRP) from baseline at Week 24, was within the predefined equivalence margin indicating equivalence in clinical efficacy between Riabni and rituximab RP. Safety, pharmacokinetics and immunogenicity of Riabni were similar to rituximab RP.

Related article
Biosimilars approved in the US

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View this week’s headline article: Estado actual de los biosimilares de anticuerpos monoclonales aprobados en América Latina

Browse the news in the Latin American Forum!

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

LATIN AMERICAN FORUM

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Estado actual de los biosimilares de anticuerpos monoclonales aprobados en América Latina

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. 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 2022 Jun 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
2. Derbyshire M, Shina S. Patent expiry dates for best-selling 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 Kashiv Biosciences’ filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/news/fda-approves-kashiv-biosciences-filgrastim-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves Amneal’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/news/fda-approves-amneal-s-bevacizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-rituximab

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 © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: Amgen, Amneal, FDA

comment icon Comments (0)
Post your comment
Related content
FDA approves biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilars/News Posted 07/10/2022
EC approves bevacizumab biosimilar Vegzelma
Anaemia 2 V13J18
Biosimilars/News Posted 23/09/2022
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