Biosimilarity vs. “Cognitive Dissonance”: The Ongoing Challenges to New FDA Pathway

FDA is still awaiting its first biosimilar product application – and there is no reason to expect a flood of products any time soon. The new pathway faces legal, logistical and resource obstacles. But the most important barrier may be the need for a mindset change.

Center for Drug Evaluation & Research Director Janet Woodcock kicked off her presentation to an FDA/Drug Information Association meeting on the new biosimilar regulatory process with a detailed history lesson.

She recounted the history of CDER's work in building the pathway, which—in her mind, at least—began nearly a decade ago...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approval Standards

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls

 
• By 

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

More from Pathways & Standards

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.