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Biosimilars name, notification debates rage on in the US, but costs still 'elephant in the room'

 
• By Donna Young

Whatever the ultimate outcome turns out to be for the debates in the US over the naming of biosimilars or prescriber notification of interchangeable products, the medicines are bound to be "among the most deeply analyzed and predictable" drugs to hit the US market, said Dr Emily Shacter, a former Food and Drug Administration official and now an independent consultant with ThinkFDA.

Whatever the ultimate outcome turns out to be for the debates in the US over the naming of biosimilars or prescriber notification of interchangeable products, the medicines are bound to be "among the most deeply analyzed and predictable" drugs to hit the US market, said Dr Emily Shacter, a former Food and Drug Administration official and now an independent consultant with ThinkFDA.

"I can assure you that all scientific rigor will be brought to bear," Ms Shacter declared at a 4 February all-day forum in Washington hosted by the Federal Trade Commission...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.