Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more
Last week, Senator Orrin Hatch of Utah introduced the “Hatch-Waxman Integrity Act of 2018,” which seeks “to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” ...more