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2015: US Biosimilars’ Year of Reckoning

 
• By Melanie Senior

This year will be one of reckoning for US biosimilars: the four known submissions to the FDA’s biosimilar pathway will between them stress test all aspects of the regulatory framework. The coming months will determine how far FDA can go in support of biosimilars – and how far innovators are prepared go in defense of their portfolios.

This year will be one of reckoning for US biosimilars. The four known submissions to the FDA’s biosimilar pathway will between them stress-test all aspects of the regulatory framework. Within as little as six months from now – hemmed in by the pathway’s 10-month review time – FDA will be forced to show its hand on the appropriate balance of analytical versus clinical data, on non-proprietary naming, on labeling, and on indication extrapolation across four different molecules of varying size and complexity.

Granted, FDA has always maintained that it will consider each candidate on a case-by-case basis. But the quartet of

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

 
• By Eleanor Malone

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

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: 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 the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By Ashley Yeo

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

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Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By David Wild

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.