EMA approves adalimumab and pegfilgrastim biosimilars

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab biosimilar Hulio and also for the pegfilgrastim biosimilars Pelgraz and Udenyca.

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Hulio is produced by US generics giant Mylan and partner Fujifilm Kyowa Kirin Biologics. The pair had their candidate adalimumab biosimilar (FKB327) accepted for regulatory review by EMA in May 2017 [1]. Mylan made a deal with Fujifilm Kyowa Kirin Biologics in April 2018 giving it exclusive commercialization rights for FKB327 in Europe [2].

The pegfilgrastim biosimilar, Pelgraz, is produced by US generics company Accord Healthcare (Accord), a subsidiary of India-based Intas Pharmaceuticals, while Udenyca is from ERA Consulting.

The CHMP has recommended that Hulio (adalimumab) be approved for the treatment of certain inflammatory and autoimmune disorders. For Pelgraz (pegfilgrastim) and Udenyca (pegfilgrastim) the committee has recommended that they be approved to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

The positive CHMP opinion for Hulio was based on similarity assessment in analytical testing, preclinical and clinical studies that, according to Mylan, ‘demonstrated biosimilarity to the adalimumab reference product, Humira’. The data submitted also included the phase III clinical study, ARABESC, which was conducted by Fujifilm Kyowa Kirin Biologics. This trial, according to Mylan, ‘demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients’.

The positive CHMP opinion for Pelgraz was based on Pelgraz’s substantial clinical development programme, which supported its biosimilarity with Neulasta through a phase I, randomized, assessor-blinded pharmacokinetic/pharmacodynamic study in healthy volunteers, and a phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).

Seven adalimumab biosimilars have already been approved for use in the European Union. Amgen’s Amgevita and Solymbic received European Commission approval in March 2017, Imraldi, produced by Samsung Bioepis, received approval in August 2017 and Boehringer Ingelheim’s Cyltezo (BI 695501) received approval in September 2017 [3]. Then in June 2018 EMA approved three adalimumab biosimilars from Sandoz, Halimatoz, Hefiya and Hyrimoz [4].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-adalimumab-biosimilar-from-Fujifilm-Kyowa-Kirin-Biologics
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Fujifilm-Kyowa-Kirin-Biologics-partner-on-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-trastuzumab-biosimilars

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Source: Accord,EMA, Mylan

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