Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors
US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.
You may also be interested in...
US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.
Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.
New drug pricing program under the Inflation Reduction Act could reduce the value of the 340B drug discount for safety net providers by as much as $1 billion in the first year, an analysis by the 340B Health association suggests.