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EU Officials Note Similarities In Post-Approval Changes For Biosimilars, Reference Drugs

EU pharmaceutical and industry officials note some common trends and similarities in post-approval changes for biosimilars and reference products. One vexing problem in instituting post-approval changes is whether to use the reference drug or the approved biosimilar and regulatory guidance in this area is lacking.

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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Pipeline Watch: Phase III Readouts For Guselkumab, Volanesorsen And Dupilumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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Teva Leads Generic Rivals In First-To-File ANDAs By A Long Shot

Teva has submitted 13 ANDAs with first-to-file opportunities to FDA this year, while rivals Mylan, Endo, Sandoz and Indian firm Hetero each have filed two ANDAs with FTFs, according to public data released by the agency and further analyzed by Teva.

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