A Jan. 30, 2019 statement by FDA Commissioner Scott Gottlieb, M.D., noted, “There are a number of complex drugs that are no longer protected by patents or exclusivities that would forestall generic approval, yet they continue to face no generic competition owing to the difficulty of developing generics. The agency has advanced many new policies to help promote generic competition to complex medicines once patents and exclusivities have lapsed, and we’re planning additional policy steps in 2019.” Among those steps were the following:
• Issuance of additional guidance documents
• Addressing categories of complex drugs that are difficult to copy
• Providing a series of guidances to address regulatory and scientific challenges (including guidance with recommendations on establishing active ingredient sameness)
• Development of new analytical tools and in vitro tests that can reduce complex generic drug development time and cost and can inform regulatory decisions
Said FDA, “Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of our Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.”
According to a report from Zion Market Research, the global generic drug market will reach a value of $380.60 billion by 2021, which represents a 10.8% CAGR between 2016 and 2021. Cardiovascular and central nervous system therapies were singled out in the report as leading and growing generic drug areas.