EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, has been accused of proving to be a barrier for the development of clinically superior compounds.

Schellekens and Moors highlighted six areas where they believe that the EMA comparability requirements are unnecessary and claim that clinical trials alone are sufficient. Their arguments include that:

• Identification and verification of quality attributes of the biosimilar product should be sufficient for approval of a biosimilar product, without comparison with a reference product.
• Comparative pharmacokinetic data should not be required at all if clinical efficacy and safety data in the end appear to prevail and drive the regulatory decision for approval of biosimilars.
• Only the evaluation of what the CHMP accepts or rejects will define what a biosimilar is, and that there is no definition of acceptable differences in quality, safety and efficacy.
• Comparability requirements can force biosimilars producers to use ‘old technologies’ rather than produce biosimilars using the best available technology at the current time.
• The pathway does not apply to ‘more poorly’ purified biologicals that are more complex and difficult to characterise than a highly purified recombinant DNA–derived biological like erythropoietin or filgrastim.
• Schellekens and Moors also propose extending the scope of biosimilar legislation to cover complex non-biological products.

The Working Party on Similar Biological Medicinal Products (BMWP) of EMA in their response argue that data on both analytical and clinical comparability are necessary to facilitate the proper development of biosimilars and even go so far as to question the scientific soundness of Schellekens and Moors proposals, considering their arguments misleading—even incorrect—from a scientific perspective. They see no reason to remove the requirement for a three-level comparability exercise, which includes quality, non-clinical and clinical aspects, and argue that the comparability requirements have already proven their value in the marketing authorisation of appropriately developed biosimilar products.

The series of articles that follows provides a more detailed look into the response and arguments of the EMA’s BMWP in its defence of its comparability requirements as part of the biosimilars pathway in Europe.

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Source: www.gabionline.net