Europe – EMA shares lessons learned from biosimilars pilot

The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.

Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are conducted before analytical comparability studies, do not reflect current industry trends where clinical studies are conducted in tandem with analytical comparability studies.

The scientific advice program was launched in February 2017 to advise developers of biosimilars on the studies they should conduct, based on a review of available quality, analytical and functional data and to explore the stepwise approach to biosimilar development. (RELATED:  EMA to Launch Tailored Biosimilar Scientific Advice Pilot, Regulatory Focus, 16 December 2016)…