German pharmacies to mandate biosimilars over biologics by 2026
From April: Pharmacies must switch to biosimilars
It's finally happening: From April, pharmacies will also have to switch to biosimilars. The Joint Federal Committee (G-BA) has decided the rules and included them in a new § 40c of the Drug Directive (AM-RL). This means not only the delivery sequence has to be considered, health insurers can also negotiate rebates in this area.
2025-04-12T04:26:00+00:00
medical-conditions, health-and-wellness, finance, business
German pharmacies will soon follow new rules for dispensing biological medicines. Starting in 2026, they must replace prescribed biologics with approved biosimilars for insured patients. The change aims to streamline treatment while maintaining safety and effectiveness.
The Federal Institute for Drugs and Medical Devices (BfArM) has set out the guidelines for substitution. These rules allow swapping a reference biologic with its biosimilars—or between biosimilars of the same original product. For substitution to happen, the alternative must match the prescribed drug in indication, strength, packaging, and form.
The rules will take effect in 2026, ensuring biosimilars replace biologics where appropriate. Patients and prescribers retain some control over the process, with safeguards for individual cases. The shift is expected to affect how insured patients receive their biological treatments.
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