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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A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.
A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.
The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.