The primary importance of the production process was demonstrated when changes in the production process of an originator recombinant erythropoietin resulted in patients developing pure red cell aplasia. Today we say “the process is the product”. The European biosimilar framework does not require developers to use a manufacturing process for a biosimilar that is identical to the one taken for the reference product. It acknowledges that “it is not expected that the quality attributes in the similar biological and reference medicinal products will be identical.” Thus, even if manufacturing processes deviate from each other and thus inevitably lead to distinct quality attributes, such as process- and product-related impurities, the biosimilar development pathway is not per se excluded. So an understanding has developed that these compounds are not interchangeable in the same way as generic versions of drugs. But although the biosimilars may differ noticeably from each other and originator medicines, they are not inferior, just different.

Similar questions to those being asked about the first biosimilars in 2004 are now being asked about biosimilar monoclonal antibodies (mAbs). But with the confidence built from experience, it is expected that the regulatory authorities and the biotech industry will work together to produce standards suitable for the next generation biosimilar mAbs.

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Approval of biosimilar epoetins: how similar are they?

References

Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm. 2004;10(3):43-7.

Cameron JS. European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 1999;14(S2):61-5.