Biosimilars are gaining U.S. momentum even as patent thickets keep triggering legal fights, small biotechs are feeling the pressure of the FDA’s faster-moving approval environment, and the agency is testing real-time clinical trial review with big-name drugmakers already on board. It’s a fast-changing drug-development landscape worth watching. Don’t miss the latest:
As Biosimilars Gain Traction, So Does FDA Scrutiny
Source: PharmaVoice
Biosimilars are gaining traction in the U.S. as FDA policy changes and major deals like Sun Pharma’s Organon acquisition push the market forward. Meanwhile, patent thickets are still slowing entry by forcing biosimilar makers into costly litigation and delaying competition for branded biologics.
FDA’s Need for Speed Could Strain Small Biotechs
Source: PharmaVoice
The FDA’s push to speed up drug approvals is raising the pressure on small biotechs, which often have fewer resources, less flexibility, and little room for a failed first filing. The piece explains that companies can keep up by staying in close contact with the FDA, confirming guidance hasn’t changed, and documenting development plans carefully as the agency navigates staffing strain and political uncertainty.
FDA Chief Marty Makary Resigns
Source: The Associated Press
The head of the Food and Drug Administration, Dr. Marty Makary, has resigned after just over a year in the role, capping a turbulent tenure marked by internal upheaval, political pressure, and mounting criticism from across the health sector. Despite efforts to streamline drug approvals and overhaul agency practices, Makary struggled to maintain a positive reputation amid layoffs, leadership turnover, and controversial decisions.
