The FDA Commissioner called on payers to take steps to build the US biosimilar market and discouraged some early contracting schemes, calling them pay-for-delay tactics "dressed in the guise of rebates" in a notable speech at AHIP.
FDA Commissioner Scott Gottlieb took the stage at America's Health Insurance Plans (AHIP) National Health Policy Conference March 7 with a searing message for insurers: take a more proactive role in fostering the early biosimilar market or else a "rigged" system could scare biosimilar competition out of the market altogether.
The speech was notable for the aggressive tone in which the FDA leader targeted insurers, pharmacy benefit managers and drug...
Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
