With an eye toward interchangeable insulins, FDA commissioner says existing protein products that will be 'deemed to be licensed' as biologics in March 2020 will not gain any additional exclusivity; coupled with the loss of existing unexpired exclusivity, the decision may spur innovator lawsuits against the agency for an unconstitutional 'taking.'
US FDA Commissioner Scott Gottlieb has officially closed the door on 12-year exclusivity for currently approved insulins and other protein products that will be "deemed to be licensed" under the Public Health Service (PHS) Act in March 2020, a move that is likely to open the door to litigation against the agency from innovators.
"We will not confer exclusivity that sponsors never expected nor were intended to receive," Gottlieb said Dec. 11 at the...
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
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.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
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.
