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Pros and Cons of FDA Process for Follow-On Biologics

Discuss the pros and cons of FDA developing an AnDA- like process for "follow-on" biologics.

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I am not sure how much detail you need, but I will summarize the important points on this issue below. I did some research for you and will also give you some references to useful web sites as I go along.

Follow-on biologics are similar to generic drugs in that they are intended to have the same therapeutic purpose as the original. Biologics are defined as substances used in medicine that are produced by living things. These substances are usually quite complex. Follow-on biologics are developed independently and may or may not have the same molecular structure as the original product. Follow-on biologics are currently required to go through a full product licensing application. Establishing an ...