Germany is preparing to recalibrate the balance of power in the biologics market again. The move underscores the country’s willingness to squeeze drug budgets without alienating clinicians or undermining patient safety. The Federal Joint Committee (G-BA) has finalized the conditions under which pharmacists can exchange physician-prescribed biologics for lower-priced biosimilars at the point of dispensing. The policy, published yesterday, sets the stage for one of Europe’s most consequential access shifts, moving towards implementation no earlier than April 2026.
When it comes to chemically synthesized drugs, Germany followed the aut idem framework, a tight cost-effectiveness standard. But for complex biologics and high-priced molecules, they were treated as a separate class, buffered by safety concerns. At the moment, treatment options like infusion and injection solutions follow this framework. These medications might require physicians to be administered and prepared in the pharmacy.
The G-BA’s new rule signals that those carve-outs are narrowing. And because Germany remains one of Europe’s largest biologics markets, manufacturers are now staring down a structural inflection point for biosimilar competition.
The G-BA makes clear the political pressure behind the decision. According to impartial chair Josef Hecken, “The legislative intent behind its mandates to the G-BA is clear: it is about saving costs for the insured community, also in the area of biologics. The G-BA’s task is therefore to promote the prescription and dispensing of more affordable biologics – without jeopardizing drug therapy safety or patients’ access to medical progress”
The implementation architecture is detailed but not overly prescriptive, a sign that Germany wants to build a high-trust, compliance-driven market rather than a blunt, mandatory switching regime. The rule applies to a broad range of subcutaneous and infused biologics, including insulins, clotting factors, and antibody-based therapies, categories that collectively drive a significant portion of Germany’s specialty-drug expenditure.
Pharmacies will now be empowered, and in many cases obligated to substitute a prescribed biologic with a cheaper biosimilar if key criteria are met.
- Shared indication and administration route: A biosimilar must be approved for at least one of the same therapeutic uses and for at least one of the same administration methods as the prescribed product.
- Identical strength and pack size: The interchangeable product bears the same dosage, strength, and package size. Additionally, the product with the same dosage form bears the same container (for instance, pre-filled syringe, pre-filled pen, cartridge, and so on). Interchangeable with the original container format to avoid confusing patients accustomed to specific injection techniques.
- Substitution can occur not only between a reference biologic and its biosimilars but also between biosimilars referencing the same originator. Interchange occurs only when authorized for the same medical product.
Pharmacies will rely primarily on Annex VIIa, a continually updated catalog mapping reference biologics to their approved biosimilars. Software systems and pricing databases will remain essential, but Annex VIIa becomes the formal backbone of switching decisions.
If a patient’s insurer has negotiated a discount agreement for a specific biosimilar, cost-effectiveness is automatically satisfied; no further economic comparison is required. This gives insurers a powerful new lever in contracting and is expected to drive more aggressive rebate negotiations.
Germany is not adopting a blanket switch-all model. Prescribers may explicitly prohibit substitution on clinical or therapeutic grounds, and pharmacies may decline to switch when patient-specific factors surface, such as documented intolerances, past adverse reactions, or device-related challenges.
This dual-override structure is likely to reassure clinicians who traditionally worry about non-medical switching but still gives insurers and pharmacies enough latitude to materially shift utilization patterns.
Since 2020, German physicians have been required to follow G-BA guidelines for cost-effective biologic prescribing, defined in Section 40a and Annex VIIa. In 2024, the G-BA extended guidance to pharmacies for infusion and injection solutions. The new Section 40c now completes the legislative mandate by addressing finished medicinal products administered via common outpatient delivery formats.
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Once reviewed by the Federal Ministry of Health and published in the Federal Gazette, the regulation will go live no earlier than April 2026.
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