Dive Brief:
- The Food and Drug Administration has announced draft guidance for formal meetings between the FDA and companies seeking approval for biosimilar products. Comments should be submitted by September 4, 2018.
- The document discusses good meeting management practices (GMMPs) and standardized procedures for requesting, preparing, scheduling, conducting and documenting the meetings.
- The FDA has also committed to specific performance goals that include management goals for formal meetings.
Dive Insight:
Biologics often allow for greater precision and can hit a broader range of targets than small molecule drugs. However, their more complex development makes them costlier to produce. Many also command top-tier price tags. This is where biosimilars come in, as lower cost, (near) copies of off-patent branded biologics.
According to the Rand Corporation, biosimilars could reduce direct spending on biologics in the U.S. by $54 billion over the decade from 2017 to 2026. In theory, these savings will not only be driven by the lower cost of the biosimilars, but also by the increased competition within drug classes.
The U.S. biosimilars market has lagged behind Europe, which created a legal avenue for them years earlier. The 2010 Affordable Care Act created that pathway in the U.S. and it is only starting to bear fruit.
Since 2015, the FDA has approved eleven biosimilars (ten on that list plus the recently approved biosimilar of Amgen's Neulasta). That compares with 43 in Europe.
Only three of those eleven biosimilars in the U.S. have actually reached patients, though, as patent hurdles have prevented many from entering markets.
One of the aims behind this new guidance is to make the development process more efficient and effective, for both the agency and the sponsors. By increasing the pathways to the market, this move by the FDA could help to increase competition.
Companies developing biosimilars in the U.S. under the Biosimilar User Fee Act (BsUFA) can ask for several types of meetings with the FDA: Biosimilar initial advisory (BIA) meetings and biosimilar biological product development (BPD) meetings type 1, 2, 3, and 4.
These tie in with different stages of development and will support the development and review of the biosimilar. The recommendations formalize the structure of these meetings, and set timeframes on when the FDA needs to respond to meeting requests from industry.