What should a biotechnology company submit with the Marketing Authorisation Application dossier for a follow-on biologic?

A biotechnology company is required to submit a full quality dossier along with a demonstration of comparability for a follow-on biologic in the Marketing Authorisation Application (MAA) dossier. This is crucial because follow-on biologics, also known as biosimilars, must demonstrate that they are highly similar to the reference product in terms of quality, safety, and efficacy.

The full quality dossier contains detailed information about the manufacturing process, controls, and characterizations of the biological product. This is essential for regulatory authorities to assess the consistency and reliability of the product. The demonstration of comparability, which includes analytical studies, non-clinical studies, and sometimes clinical trials, is needed to establish that any differences between the follow-on biologic and the reference product do not impact the safety or efficacy.

This comprehensive approach helps ensure that the follow-on biologic can be considered therapeutically equivalent to the reference biologic, providing assurance to prescribers and patients regarding its use. Thus, the requirements emphasize the importance of extensive data on quality and the demonstration of similarity to the reference product.