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What is difference between 351(a) vs. 351(k) pathway?
13 Sep 2017

What is difference between 351(a) vs. 351(k) pathway?

351(a) is the original approval pathway for biologics. It is the pathway for approval of innovator biologics. It is also known as the traditional pathway for approval of innovator biopharmaceuticals.

351(k) biologics license application is the biosimilar application process in USFDA. Read more

At a Glance

  • 351(a) is the original approval pathway for biologics.
  • It is the pathway for approval of innovator biologics.
  • It is also known as the traditional pathway for approval of innovator biopharmaceuticals.
  • 351(k) biologics license application is the biosimilar application process in USFDA.

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