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Posted On: 09/25/2021 10:16:04 PM
Post# of 154989
Here's a good reference link from the FDA about patents and exclusivity.
https://www.fda.gov/drugs/development-approva...xclusivity
What really worries me on timelines is "biosimilars". If someone comes up with a molecule they can prove is "similar" to LL, then they don't need to conduct the extended Phase 3 and 4 trials to bring their product to market. All they effectively need to demonstrate is safety and efficacy.
Here's a good starting link on FDA's biosimilar program:
https://www.fda.gov/drugs/therapeutic-biologi...iosimilars
https://www.fda.gov/drugs/development-approva...xclusivity
What really worries me on timelines is "biosimilars". If someone comes up with a molecule they can prove is "similar" to LL, then they don't need to conduct the extended Phase 3 and 4 trials to bring their product to market. All they effectively need to demonstrate is safety and efficacy.
Here's a good starting link on FDA's biosimilar program:
https://www.fda.gov/drugs/therapeutic-biologi...iosimilars
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