A landmark decision by German health authorities has cleared the way for pharmacists to independently substitute biological medicines for more cost-effective biosimilars.
The Gemeinsamer Bundesausschuss (Federal Joint Committee) has formally amended the Arzneimittel-Richtlinie(Pharmaceutical Directive) by introducing the new section § 40c. This resolution, Austausch von biotechnologisch hergestellten biologischen Fertigarzneimitteln durch Apotheken (Substitution of biotechnologically manufactured biological finished medicinal products by pharmacies), represents a fundamental shift in the country’s drug-dispensing doctrine.
Previously, the selection of a specific biological brand was exclusively the responsibility of the prescribing physician. Under the new rules, pharmacies are now required to substitute a prescribed reference biological with a cheaper biosimilar, provided the products are listed as interchangeable in the newly created Anlage VIIa (Annex VIIa). This initial implementation phase focuses on adalimumab, a therapy for inflammatory conditions, which will serve as the pilot for broader application.
Professor Josef Hecken, the Unparteiischer Vorsitzender (Impartial Chairman) of the Gemeinsamer Bundesausschuss, noted that the move is designed to harness significant savings. The committee concluded that sufficient clinical data are available to ensure that pharmacy-level switching does not compromise patient safety. This is a new, permanent doctrine that moves biological therapies toward the ‘aut-idem’ substitution model already standard for chemical generics.
The measures were adopted on 4 December 2025 and will enter into force following their official publication in the Bundesanzeiger (Federal Gazette). The implementation will require pharmacies to update their software systems to reflect the new substitution list. While the policy is intended to lower healthcare expenditure, it is expected to lead to intensified competition and potential shifts in market share for several major biopharmaceutical manufacturers.
Source – Gemeinsamer Bundesausschuss, G-BA
Link: Pharmaceuticals Directive (AM-RL): Section 40c on pharmacy substitution of biologic medicinal products
Date: 4 December 2025