As U.S. biosim market grows, FDA's regulatory work has cost nearly $82 million
- The FDA has spent nearly $82 million on its biosimilar development program since it was implemented in 2013, according to a new report from the independent Eastern Research Group (ERG).
- Since the program’s launch, seven biologics license applications have been submitted through the 351(k) pathway, with only Sandoz’s Zarxio reaching approval as of September 30, 2015.
- The number of biosimilar programs has steadily increased each year to 57 in 2015, up from 33 in 2013. (This doesn’t include the 7 biosimilar applications as those programs have exited biosimilar development.)
The report from ERG lays out the current biosimilars development program landscape at the FDA. It paints a picture of a steady increase in work related to biosimilars as the U.S. market evolves.
Meetings between the industry and the FDA have accounted for the most amount of work, particularly BPD Type 2 meetings which discuss issues such as study design or trial endpoints.
Other areas, however, have seen a decrease in meeting-related workload. Specifically, there has been a decrease in the number of industry-scheduled biosimilar initial advisory meetings, as well as a decrease in the number of meetings for in-depth data review and advice on ongoing programs.
Looking more closely at the meeting-related data, it seems that companies coming to the FDA to discuss their biosmilar development programs have gone beyond the initial steps and are now seeking guidance for specific issues, or hitting specific milestones where additional advice/oversight may be required.
Although the development of a thriving, robust biosimilars industry in the U.S. is evolving slowly, this report indicates the regulatory work associated with the sector’s development is beginning to ramp up.