Germany Sets Direction Of Travel With New Biosimilar Guidelines
Originator Companies Will Strike More Rebate Contracts And Promote Safety
Germany is for the first time to adopt national guidelines on prescribing biologics and biosimilars in move towards increasing biosimilar uptake.
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The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.
A German bill aims to cut spending on biologics, but new revisions mean that measures on biosimilar substitution are likely to be delayed by three years.
Draft guidelines due out for consultation this week in Italy are expected to shed more light on what companies will have to reveal during pricing and reimbursement negotiations.