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June 28, 2018


Sorry, all, for any confusion. The relevant provisions are Sections 351(k) and 351(l) of the PHS, codified at 42 USC Sec 262(k) and 262(l). We're working on correcting it in the text

Updated FDA data: According to Biocentury, the number of biosimilar applications is back up to 68, the same as it was last year before FDA approved several of the pending applications.

Thanks to BioCentury for the updated information.

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