FDA prioritizes safety over cost for biologics and biosimilars

FDA’s new guidance on the agency’s evolving thinking on real world evidence in device applications may foreshadow what we can expect for drugs and biologics. More here: https://lnkd.in/efcGxYmW

New Series about USFDA Day 13 FDA Doesn’t Believe in ‘We Will Fix It After Approval Did you know? FDA sees “post-approval commitment” as pre-approval avoidance. Especially in biologics & biosimilars, FDA asks: Why wasn’t this risk addressed earlier? What stopped you? Who accepted the risk? If the answer is: Timeline pressure Market competition Investor expectations FDA documents quality compromise. Regulatory trust is built before approval — not after.

Worried about CMC risks or delays in your biologics programs? In this on-demand webinar, Lonza experts share real project examples showing how drug substance/drug product alignment strengthens coordination, quality, and regulatory readiness across global sites. Learn how integrated planning and execution can streamline your next biologics program. Watch here: https://ow.ly/U9WO30sRYoL

Worried about CMC risks or delays in your biologics programs? In this on-demand webinar, Lonza experts share real project examples showing how drug substance/drug product alignment strengthens coordination, quality, and regulatory readiness across global sites. Learn how integrated planning and execution can streamline your next biologics program. Watch here: https://ow.ly/ybbf30sRU4h

Worried about CMC risks or delays in your biologics programs? In this on-demand webinar, Lonza experts share real project examples showing how drug substance/drug product alignment strengthens coordination, quality, and regulatory readiness across global sites. Learn how integrated planning and execution can streamline your next biologics program. Watch here: https://ow.ly/p69E30sRUQg

The FDA has published a revised Biosimilarity recommendation, offering a pathway to more efficient biosimilar approvals. The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway. - What does this mean for sponsors? Under this streamlined approach, when the comparative analytical assessment (CAA) proves that the candidate biosimilar closely resembles its reference product, a CES may not be required, providing the stated conditions are met. - At Scendea, we have a team of leading biosimilar experts with extensive experience supporting a broad range of biosimilar development programs across multiple therapeutic areas. Get in touch to understand how our experts can support your biosimilar product development: www.scendea.com/contact - #immunogenicityriskassessments #pharmacokineticstudies #biosimilars #drugdevelopment

Outlook Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the ONS-5010/LYTENAVA (bevacizumab-vikg) Biologics Licence Application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet Age-related Macular Degeneration (AMD). Read more: https://lnkd.in/gHFJbu2z #PharmaNews #Biotech #RegulatoryUpdate #DrugApproval #PharmaIndustrialIndia

The FDA has recently published its internal filing checklists for New Drug Applications (NDAs) and Biologics License Applications (BLAs) - a major step toward transparency and efficiency in regulatory submissions. But what does this mean for Applicants, and why should you still engage a regulatory consultant to support filing? Swipe through our latest slide deck for:  • A breakdown of the FDA’s checklist release and its impact  • Why expert regulatory guidance remains essential, even with detailed checklists now available Whether you’re preparing your first submission or navigating the marketing authorization process for a complex product, this resource will help you understand the expectations and how to maximize your chances for a successful, first-cycle review. Let’s connect and discuss your next filing! #FDA #NDA #BLA #RegulatoryAffairs #Pharma #Biotech

How do we align our QMS with regulatory compliance for biologics testing? See our team’s careful plan to ensure our customers’ success: https://okt.to/SUjovd