EMA releases finalized guideline on facilitating global development of Biosimilars

The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.

The new guidance was published to update the existing guideline from October 2005 on the principles for establishing biosimilarity. As per the EMA, the purpose of this guideline is to describe and explain the concept of similar biological medicinal products and the principles to be applied. It explains that products that are considered “highly purified and can be thoroughly characterized” are more likely to be successful with this biosimilar approach.

EMA describes a biosimilar as a biological medicine that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the EEA. As per the regulators of EMA, in order to get a biosimilar approved, the developer must demonstrate that the medicinal product “is as safe and effective as the reference [medicinal product].”

A biosimilar must demonstrate similarity to the reference medicinal product in terms of the following:

  • Quality characteristics
  • Biological activity
  • Safety
  • Efficacy

Due to the complexity of biological/biotechnology-derived products, the biosimilar approach, based on a comprehensive comparability exercise is essential to be established to display similarity unlike the standard generic approach used for most chemically-derived medicinal products. The similarity should exist in terms of physiochemical and biological characterization and comparison. Differences identified must be justified concerning any potential impact on safety and efficacy.

Importantly, while the EMA requires all references products to be authorized in the EEA, they are cognizant that to facilitate “the global development of biosimilars and to avoid unnecessary repetition of clinical trials,” there may be a possibility for drug product developers to compare the “biosimilar in certain clinical studies and in in vivo non-clinical studies with a non-EEA authorized [product].” However, the non-authorized comparator must be “authorized by a regulatory authority with similar…scientific and regulatory standards as…EMA.” Drug product developers will need to establish that the non-EEA authorized “comparator is representative of the reference medicinal product authorized in the EEA.”

The attached guidance further clarifies the recommendations, requirements and procedures concerning the establishment of biosimilars in the European Union.



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