Biotech giant Amgen and China-based Simcere Pharmaceutical Group (Simcere) announced on 26 September 2017 that they have made an exclusive agreement to co-develop and commercialize four copy biologicals in China.
The deal includes ‘undisclosed biosimilars in the areas of inflammation and oncology’, which ‘are a part of Amgen’s existing biosimilars portfolio’. The press release states that Amgen will ‘remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars’, while Simcere ‘will be responsible for distribution and commercialization in China’. Amgen will also gain ‘a limited right to co-promote the products’.
Scott Foraker, Vice President and General Manager Biosimilars at Amgen, said the ‘agreement brings together Amgen’s long-standing development and biologic[al]s manufacturing expertise with Simcere’s local development experience and strong commercial presence in China in the areas of inflammation and oncology’.
Amgen already had its adalimumab biosimilar Amjevita (adalimumab-atto)/Amgevita (ABP 501) approved by the US Food and Drug Administration in September 2016 [1] and by the European Medicines Agency in January 2017 [2]. In its pipeline are biosimilars of cancer treatments bevacizumab (ABP 215), cetuximab (ABP 494) and trastuzumab (ABP 980), as well as biosimilars for arthritis treatments infliximab (ABP 710) and rituximab (ABP 798).
Simcere has already had a copy biological version of etanercept – Qiangke – approved by the Chinese authorities [3].
Editor’s comment
It should be noted that ‘copy biologicals’ approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
3. GaBI Online - Generics and Biosimilars Initiative. TNF copy biological approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/News/TNF-copy-biological-approved-in-China
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