Craig Burton, who replaces the FDLI-bound Christine Simmon, tells the Pink Sheet that fighting rebating practices which harm insulin patients now can pave the way for successful launches of Humira biosimilars next year. Biosimilar markets should not be ‘winner-take-all,’ he says.
Incoming Biosimilars Council Executive Director Craig Burton wants the industry and policymakers to learn from the launch of insulin biosimilars in time for the widely anticipated debut of competitors to AbbVie Inc.’s Humira (adalimumab).
Burton, the Association for Accessible Medicines’ VP of policy since 2017, replaceed Christine Simmon as head of AAM’s biosimilar industry...
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.
