Biotech Values

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Woodcock said that if a biotech company develops a longer-lasting version of a drug, or otherwise alters an existing molecule to improve efficacy of safety, it would be considered a new molecule, with a new 12-year exclusivity.

A biobetter might be less lucrative than a biosimilar if the former were only marginally better and the latter were substitutable, especially if a biobetter has to generate an entire safety/efficacy package and go through the BLA approval process.