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Briefly describe the manufacturing differences between biosimilars and small-molecule generics According to the FDA guidance on...

Briefly describe the manufacturing differences between biosimilars and small-molecule generics

According to the FDA guidance on biosimilars, manufacturers should use a stepwise approach to demonstrate biosimilarity. List all of the items that need to be included in the comparison between the proposed product and the reference product

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Answer #1

Generics are copies of synthetic drugs. Biosimilars are designed on the basis of the ingredients used by living organisms.

Generics are identical to the original chemical composition. Biosimilars are highly identical but not completely.

For the next question, it requires a lot of part. So I will suggest you to make a separate question for this. Thus you will get more productive answers. For example, it contains analytical studies, animal studies and many more to be included.

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