Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.