As agency's hearing approaches, a Pink Sheet graphic charts the path for pending and approved applications for insulin, human growth hormone, and certain other protein products when the BPCIA ‘transition provisions’ take effect in March 2020.
The complex process by which dozens of protein products will shift from regulation as drugs to biologics in March 2020 may face renewed scrutiny at an upcoming US Food and Drug Administration hearing on biosimilar and interchangeable insulins.
Under the Biologics Price Competition and Innovation Act “transition provisions,” insulin, human growth hormone and certain other types of protein products historically regulated as drugs under the Food, Drug and...
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
