Biosimilars may be recombinant proteins and polypeptide products, their derivatives, and products of which they are components, e.g. conjugates. Biosimilars are proteins and polypeptide products produced from recombinant expression systems using micro-organisms or cultured cells and that can be highly purified and well-characterized using an appropriate set of analytical procedures.

A biosimilar product can generally be developed on the basis of data that demonstrates the comparability between the biosimilar product and the reference product with respect to quality, safety and efficacy, or other relevant data.

The reference products should be drugs approved in Japan and be the same product throughout the development period of the biosimilar products.

The following requirements must be met:

• It should be established that the manufacturing process for the biosimilar is highly consistent and robust.
• The biosimilar should be fully characterized using state-of-the-art analytical methods.
• The dosage form and route of administration of the biosimilar product should be the same as that of the reference product.
• Long-term, real-time, real-condition stability studies following the ICH Q5C guideline are required.
• In addition to elucidating the quality attributes of the biosimilar, comparability exercises comparing quality attributes between the biosimilar and the reference product should be conducted.
• Non-clinical studies (including pharmacokinetic, pharmacological and toxicity studies) that can ensure the safety for administration to humans should be performed and completed prior to initiation of clinical studies.
• Where the data from quality characterization and non-clinical studies is insufficient to demonstrate comparability with the reference product clinical studies are required. Clinical studies should be designed based on the data from quality characterization, non-clinical studies and comparability studies [1].

The article that follows compares the clinical requirements of the regulatory authority in Japan with that of the regulatory authorities in Canada, EU and Korea, as well as with the World Health Organization requirements.

Related articles

Comparison of biosimilars guidelines

Japanese guidelines for biosimilars

References
1.  Arato T. Recent regulations of biosimilars in Japan. Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency.
2.  Derbyshire M. Biosimilar development and regulation in Japan. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):207-8. doi:10.5639/gabij.2013.0204.055

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