Alston & Bird
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Biosimilars Are Entering a New Regulatory Inflection Point
This Advisory explains the requirements a sponsor must meet to get a biosimilar approved, the difference between biosimilars and interchangeable biosimilars, and how these differ from generic drugs under U.S. law. As biologic drugs continue to account for a growing share of healthcare spend, biosimilars are poised to become a major commercial and strategic force — but not through incremental change. Regulatory evolution in the U.S. is reshaping how these complex medicines are developed, approved, and ultimately marketed. The latest guidance from the FDA, and the implications that flow from it, signal a genuine inflection point for biosimilar commercialization. Responsory’s takeaway: These regulatory shifts don’t just affect CMC or regulatory affairs, they ripple through commercial playbooks: 1. Competitive dynamics will accelerate; 2. Interchangeability may no longer be a slog; 3. Education becomes a strategic priority; and 4. Launch timing matters more than ever.
