As a leading provider of high quality biologic medicines, Amgen understands the challenges of developing and manufacturing innovative and biosimilar medicines.

Amgen welcomes the European Medicine Agency’s (EMA) final Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies - Non-clinical and Clinical Aspectsⁱ. Having participated in the comment period, Amgen broadly supports the scientific principles behind the guideline, which aims at maintaining a high standard for approval of a biosimilar in the European Union (EU).

Of particular importance is the EMA acknowledgment of the important distinction between identifying differences analytically and determining their relevance to physicochemical and biological activity. Further, the agency conclusively states that distinct manufacturing processes will result in qualitative differences in process impurities. The EMA noted that qualitative and quantitative differences in product-related variants (post-translational structures, etc.) may affect biological function. While these statements may be clear to leading scientists and experienced biotech companies, the issue should now be settled for they have been in dispute among policy makers and pharmacopeias around the world.

Amgen is pleased to see that the EMA has stressed in the guideline the importance of the accurate attribution of adverse events, consistent with the expectations of the EU Pharmacovigilance Directiveⁱⁱ. It is unfortunate however that the guideline advocates simply recording the “name” of a medicine, while the Pharmacovigilance Directive makes it a legal requirement for Member States to ensure that the brand name be captured on adverse event reports.

When multiple manufacturers are marketing different versions of a monoclonal antibody medicine (mAb), identification of exactly which product a patient receives will be far more difficult. This will become a reality in the EU as soon as next year when the first biosimilar mAb could appear on the market.

Amgen believes prompt identification and resolution of product problems will be facilitated by distinguishable, established names; and supports efforts to help make this process clear and implementable.