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When it comes to FDA approval for biosimilars, the devil is in the details.
Despite a law that’s been on the books since 2009, plus a series of agency guidances clarifying the FDA’s 351(k) abbreviated licensing application pathway for biosimilars, surprisingly few drugmakers really understand what the FDA expects.
You need someone to clear up the confusion — quickly and painlessly.
This management report from FDAnews picks up where the FDA leaves off, boiling down and simplifying the many pages of FDAisms into the language you speak every day: plain English.
We distill the most significant information from the agency’s biosimilars guidances, including critically important takeaways from the 2014 guidance on using clinical pharmacology data to show biosimilarity to a reference drug. It’s all in service of helping you understand:
- The three key evaluations for FDA review
- The three specific assays the FDA describes as “particularly important”
- Additional information on bridging studies for data derived from non-U.S. products
- The utility of modeling and simulation tools
- And much more!
You’ll discover how to ease the path to biosimilars approval by participating in the FDA’s Biological Product Development Program (BPDP) — steps, costs and benefits involved — and how to anticipate and overcome patent and other obstacles to the biosimilars market such as capital costs and clinical costs. By the time you finish reading — an hour or two at most — you’ll have a clear understanding of using the new 351(k) pathway to your best advantage.
There’s no need to find the FDA’s draft guidances in preparation for study. They’re reproduced in full in the Appendix to Successful 351(k) Biosimilar Applications.
The market for biosimilars is set to explode over the next decade. Top biologics losing patent protection by 2020 alone account for more than $60 billion in worldwide sales. Claim your piece of this enormous pie! Get on board as the FDA finalizes its regulatory framework.
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