FDA decision ends Boehringer Ingelheim’s exclusivity for interchangeable biosimilar of Humira after just a few months. Pfizer reveals pricing and launch information for its Abrilada version of adalimumab.
A US Food and Drug Administration decision around the timing of exclusivity for first interchangeable biosimilars has resulted in Pfizer being awarded an interchangeability designation for its Humira (adalimumab) rival, barely three months after the first interchangeable biosimilar from Boehringer Ingelheim hit the market.
Biosimilars designated as interchangeable in the US – meaning they can benefit from pharmacy-level substitution, subject to state law –...
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.
