Biopharma execs will soon get a chance to contribute their thoughts about the new regulations governing the development of biosimilars. The FDA is planning two days of hearings in early November to glean the ideas of interested parties, and there are likely to be quite a few coming from the development side of the business.
According to a draft document The Hill found circulating among lobbyists, the FDA will seek:
- Scientific and technical factors related to a determination of biosimilarity or interchangeability;
- The type of information that may be used to support a determination of biosimilarity or interchangeability;
- Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; and
- The scope of the revised definition of a "biological product." And more on guidance development priorities, product exclusivity and user fees.
You can expect plenty of keen attention from biotech and pharma leaders, who won a coup when Congress agreed to extend 12 years of patent exclusivity on biologics as it laid out a pathway on approvals for biosimilars. Some big companies, including Merck, are making biosimilar development a major initiative.
- here's the story from The Hill