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