After A Decade Of US Biosimilars, ‘The Challenges Are Becoming More Clear’

Biosimilars Council Chief Craig Burton Discusses Progress And The Road Ahead

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

Biosimilars are entering their second decade on the US market (Shutterstock)

A decade on from the very first US biosimilar approval, and 15 years on from the Biologics Price Competition and Innovation Act framework that provided the framework for the US Food and Drug Administration biosimilars pathway, Craig Burton – executive director of the Biosimilars Council within the US Association for Accessible Medicines – is clear on the progress made for biosimilars so far.

More from Interviews

Celltrion Plans Multiple US Biosimilar Launches In An ‘Exciting And Momentous’ Year

 
• By 

With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.

‘Our Commitment Is Serious’: Fresenius Kabi’s CEO Pierluigi Antonelli On Biosimilars And Beyond

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

IGBA’s Susana Almeida On Consensus Building, Harmonization, And Policy Built On Science – Not Politics

 

IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.

After A Decade Of US Biosimilars, ‘The Challenges Are Becoming More Clear’

 
• By 

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

More from Policy & Regulation

BGMA Hits Back At ABPI Complaints Over UK Pricing Scheme

 
• By 

Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

 

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

Regulatory Recap: Proposed FDA Head Makary To Advocate For Generics And Biosimilars

 

Generics Bulletin reviews global regulatory developments across the globe.