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About This Document: The legal barriers a biosimilar applicant faces are, however, more clear. A biosimilar application can't be filed for 4 years after the referenced originator biologic is approved, and the biosimilar product can't be approved for 12 years after that approval. The follow-on applicant who chooses the traditional BLA pathway instead can file - and be approved - at any time, lengthening the product's market lifetime.

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Categories: DocStore > Periodicals > Medicine
Tags: Pharma, Nov Dec 2011, TO BLA OR NOT TO BLA?, Halstead, David P, Feature, Pharmaceutical industry, FDA approval, Licenses, Patents, Biotechnology, 4310, Regulation, 8641, Pharmaceuticals industry, 9190, United States, United States--US

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TO BLA OR NOT TO BLA?

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TO BLA OR NOT TO BLA?

BIOSIMILARS

tO BlA OR

nOt tO BlA?

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