CER Daily Newsfeed

FDA Makes Major Move to Reduce Regulatory Red Tape for Biosimilars

(10/29, Zachary Brennan, Endpoints News) reports “...The four-page draft guidance says that the agency’s thinking around comparative efficacy studies for biosimilars ‘has evolved, and FDA has gained significant experience in evaluating data from comparative analytical and clinical studies used to support a demonstration of biosimilarity.’ A streamlined approach can be used when the biologic and proposed biosimilar are made from clonal cell lines, when the quality attributes are understood for the reference biologic, and when pharmacokinetic studies are feasible and clinically relevant, the draft says.” Subscription Required

FDA Finalizes PFDD Guidance 3 on Selecting Fit-for-Purpose Clinical Outcome Assessments

(10/29, Katie McCool, The Evidence Base) reports “...A key feature of the document is the ‘Roadmap to patient-focused outcome measurement,’ which guides sponsors in determining whether to use existing measures, modify them, or develop new ones. It emphasizes early engagement with FDA, patients, and subject-matter experts to ensure the selected COAs are appropriate for their intended context. The guidance also highlights the importance of accessibility, pediatric inclusion, and validation prior to pivotal trials.” Full

Real-World Data Standards Provide Foundation For RWE’s Global Acceptance

(10/28, Bridget Silverman, Pink Sheet) reports “...Real-world evidence is becoming increasingly sophisticated, but fundamental issues like data reliability remain central to the discussion.” Subscription Required

How AI Is Reshaping Real-World Evidence: Insights from Regulators, HTA Bodies, and Industry

(10/29, Katie McCool, The Evidence Base) reports “...Stephen Duffield (NICE) provided insight into how AI is being integrated into NICE’s evidence assessment processes. ‘AI is obviously impacting the entire evidence generation pipeline,’ he explained, noting its use in data generation, evidence synthesis, and even causal inference analyses...Duffield called for shared validation efforts: ‘If we can share our findings, our validation findings… this is how we build up the kind of case law so that we can increasingly trust certain use cases.’” Full

Reducing Spending And Enhancing Value In US Health Care: Reflections On The GAO Report

(10/29, Irene Papanicolas, Richard M. Scheffler, Health Affairs Forefront) comments “...The report also called out price differentials between the US and other countries in the area of pharmaceuticals, suggesting the government should strengthen its ability to negotiate prices by considering the relative clinical value of new drugs when setting payment. This would draw on approaches used in other high-income countries, such as health technology assessment to align the prices of new drugs with their relative values. While the new administration has also noted pharmaceutical pricing failures, the proposed Most Favored Nation policy takes a different approach: benchmarking US prices directly to those abroad rather than building a domestic process for evaluating and negotiating value.” Full