EMA Reports on Pilot Program on Tailored Scientific Advice for Biosimilar Development

On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities.

In the European Economic Area (EEA), biosimilar approval requires applicants to submit studies demonstrating similarity to the reference drug, including similarity in biologic activity, safety and efficacy. The extent of the studies required depends on the level of evidence obtained in the previous development steps, and the report notes that the EMA has recommended that biosimilar applicants discuss this in advance with regulatory authorities.

In February 2017, EMA launched a tailored scientific advice pilot program to offer development support for new biosimilar developments. Biosimilar applicants were invited to submit such requests for review to the Scientific Advice Working Party (SAWP), Biologics Working Party (BWP), Biosimilar Medicinal Products Working Party (BMWP), and Committee for Medicinal Products for Human Use (CHMP). Advice could be given on, among other things, differences between the biosimilar and reference drug identified at the quality level, the possibility of waiver of pre-clinical studies, any remaining gaps in study data, and whether the required clinical efficacy/safety trial would be waived.

In April 2020, the pilot was completed. According to the EMA report, biosimilar applicants participating in the pilot program noted that tailored scientific advice was considered to add value to the standard scientific advice for biosimilar development, and stated their appreciation for a valuable opportunity to have more in-depth dialogue with regulatory authorities.

The report also noted that a potential challenge to providing tailored scientific advice was the maturity of quality data (in some cases, quality data was from a limited number of batches or not obtained from the proposed commercial process), which made tailored recommendations regarding clinical development difficult. The report noted that setting the timing of requests for tailored scientific advice will need to be carefully considered in the future.

On September 15, 2021, EMA and FDA established a joint pilot program to provide parallel scientific advice for complex generic drug products.