Breaking News: Supreme Court Declines to Hear 'Patent Dance' Case
July federal appeals court ruling will not be heard.
According to Reuters, The US Supreme Court has declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market.
The justices opted not to take up Apotex Inc's appeal of a July federal appeals court ruling that could delay the Canadian generic drug maker's launch of so-called biosimilar versions of California-based Amgen Inc's Neulasta, used to fight infection in cancer patients.
The biosimilars law gives the maker of a biologic drug 12 years of exclusive rights before the US Food and Drug Administration can approve a biosimilar. It also states that a biosimilar maker must give the original biologic drug maker 180 days' notice before launching its copycat version.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
November 29th 2023A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 27th 2023As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
Phase 1 Study Finds Comparable PK, PD Parameters in Biosimilar GP40141 vs Reference Romiplostim
November 25th 2023A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
