Amgen welcomes biosimilar monoclonal antibody guideline

Biosimilars/News | Posted 22/06/2012 post-comment0 Post your comment

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for biosimilar monoclonal antibodies recently issued by EMA [1]. The company added that the guideline aims at maintaining a high standard for approval of a biosimilar in the EU.

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Amgen, who participated in the six-month comment period for the guideline, praised EMA for acknowledging the important distinction between identifying differences analytically and determining their relevance to physicochemical and biological activity. The agency had also conclusively stated that distinct manufacturing processes will result in qualitative differences in process impurities.

However, in the contentious area of naming, Amgen does not believe the guideline goes far enough. The company is concerned that EMA only advocates simply recording the ‘name’ of a medicine in adverse event reports, while EU Pharmacovigilance legislation, which comes into force in July 2012, demands that the brand name also be captured [2].

Amgen believes that this could lead to confusion: ‘When multiple manufacturers are marketing different versions of a monoclonal antibody medicine, identification of exactly which product a patient receives will be far more difficult.’ This could lead to problems with traceability if the active ingredient name is used; it will be difficult to identify which product from which manufacturer was actually used. ‘Prompt identification and resolution of product problems will be facilitated by distinguishable established names,’ the company concluded.

Editor’s comment
A manuscript titled ‘Pharmacovigilance of biosimilars: challenges and possible solutions’ by Dr Thijs J Giezen et al. is scheduled to be published in GaBI Journal, 2012, Issue 3. 

If you are interested in contributing a research article in a similar area to GaBI Journal, please send us your submission here.

Click here to find out more information about other manuscripts submitted for the forthcoming issue of GaBI Journal.

Related article

EU guidelines for biosimilars


1.  GaBI Online - Generics and Biosimilars Initiative. EMA finalises biosimilar monoclonal antibody guidelines []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Tighter EU rules on pharmacovigilance for biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from:

Source: Amgen, EMA

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