The Push for Generics Challenges Manufacturers

2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.

Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.

This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.

Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.

The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.

In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.

In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.