EMA rejects comparators from outside EEA for insulin biosimilars

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EMA rejects comparators from outside EEA for insulin biosimilars

Home/Guidelines | Posted 17/04/2015 0 Post your comment

The European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015 [1]. However, while the guidance took into account many of the comments made by stakeholders on the second draft, the agency rejected requests to accept batches of reference (approved) biological products sourced from outside the European Economic Area (EEA).

India-based generics maker Wockhardt had requested that EMA accept a comparator authorized outside the EEA, in the same way as is now possible for other biosimilars, according to the agency’s overarching ‘Guideline on similar biological medicinal products’ (CHMP/437/04 Rev 1) [2]. The European Biopharmaceutical Enterprises (EBE) argued that:

Insulins are generally very well characterized proteins and have been widely used for decades
No in vivo pharmacokinetic (PK)/pharmacodynamics (PD) studies are generally required for biosimilar insulin comparability exercise

EMA rejected the suggestion stating that ‘although insulins can be well characterised, differences between the EEA-sourced and non EEA-sourced original product, e.g. in formulation, may affect the PK profile and may necessitate comparative PK studies.’

The suggestion by EBE, which represents biopharmaceutical companies in Europe, to extend immunogenicity studies to include 12-month data was also rejected by EMA. The agency justified its decision by saying that ‘the majority of anti-drug antibodies is expected to develop within the first six months of treatment.’

Another suggestion made by EBE, however, on ethnicity was accepted. This led to EMA dropping its requirement for ‘manufacturers who are planning comparative clamp studies to consider reports that individuals of African, South Asian or Hispanic descent have reduced glucose clearance’. EBE pointed out that since each subject is his or her own control, ethnic differences should not matter.

Related article
EU guidelines for biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA issues finalized insulin biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Guidelines/EMA-issues-finalized-insulin-biosimilars-guideline
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of overarching biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-overarching-biosimilars-guideline

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Source: EMA