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Germany Rows Back On Plans For Biosimilar Substitution

Executive Summary

Plans to allow German pharmacists to substitute biological drugs in the same way as they do small-molecule medicines have been watered down in the latest draft of healthcare reforms.

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Bio Substitution Plan Would Put Germany On ‘Wrong Track’

Plans for substituting biological drugs at pharmacy level that have been passed by Germany’s lower house of parliament threaten to undo the good work done to date in winning trust in biosimilars, local industry association Pro Biosimilars fears.

German draft offers firms pro and cons

Positive measures including a drive to increase uptake of biosimilars are offset by more negative aspects, such as promoting pharmacy substitution of biologics and exposing cytostatic cancer therapies to tender processes, under draft medicines legislation unveiled by Germany’s ministry of health.

Pressure Mounts For German Tender Reforms

Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.

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