The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) has concluded its regulatory review of the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) decision on the mandatory substitution of biological medicines without objection. This procedural step allows the new Section 40c (§ 40c) of the Pharmaceutical Supplies Directive (Arzneimittel-Richtlinie, AM-RL) to pass into law.
Under this new system, pharmacists must substitute a prescribed biological finished medicinal product with a cheaper bioidentical version at the point of sale. The pharmacist must ensure the substitute matches the prescribed product in active substance, strength, and pack size. To maintain clinical consistency, the G-BA requires that the primary container – such as the specific pen or pre-filled syringe – is identical. This mandate applies unless the physician explicitly excludes substitution by marking the 'aut idem' box on the prescription.
The decision-making flow at the pharmacy counter prioritises products subject to rebate contracts between manufacturers and the patient’s statutory health insurance fund. In the absence of such contracts, the pharmacist must dispense one of the three least expensive versions listed in the pharmacy software. This process mirrors the long-standing generic substitution rules for small-molecule drugs. The G-BA will use Annex VIIa (Anlage VIIa) of the AM-RL as the central reference list for interchangeable bioidentical groups.
Following this launch, the G-BA will start consultations to extend these mandatory substitution rules to parenteral preparations, further expanding the reach of pharmacy-led cost-containment.
Source: Federal Joint Committee, G-BA
Link: Austauschbarkeit von Biologika in Apotheken: Regelungen des G-BA treten am 1. April 2026 in Kraft (Interchangeability of biologics in pharmacies: G-BA regulations come into force on 1 April 2026)
Date: 02 March 2026
