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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About Post Author
How Insulin will be regulated after March, 2020.Is it Biosimilar?
Sanjay Padhan
Yes, bio equivalent version of Insulin will be Biosimilar. So, Biosimilar approval pathway need to be followed.