Federal Joint Committee Sets Framework for Biosimilar Substitution in Pharmacies

The German Federal Joint Committee (G-BA) has established a new regulatory framework detailing the specific conditions under which pharmacies are permitted to substitute prescribed biologic medicines with biosimilars. This decision is the result of extensive discussions among healthcare stakeholders, including physicians, health insurance representatives, and the pharmaceutical industry.

The substitution of original biologic drugs with biosimilar alternatives has been a subject of ongoing debate in Germany. Supporters of biosimilar substitution highlight its potential to generate significant cost savings for the statutory health insurance system, which continues to face financial challenges. Conversely, representatives of the pharmaceutical manufacturing sector express concerns about increased pricing pressures potentially leading to a decline in domestic production capabilities and job losses within the industry.

According to the newly defined G-BA guidelines, pharmacies must verify several criteria before substituting a prescribed biologic with a biosimilar. The replacement product must be authorized for at least one of the same indications as the originally prescribed medicine and must have approval for at least the same modes of administration. Additionally, the biosimilar and the reference product must match in terms of dosage strength and package size, and they must have identical or compatible forms of administration. In cases where the form of administration is the same, the delivery mechanism (such as pre-filled syringes, pens, or cartridges) must also correspond.

The rules allow for substitution both from a reference biologic to its biosimilars and between biosimilars themselves, provided all products share the same reference biologic. The G-BA emphasizes that pharmacies can consult authoritative sources, including their dispensing software and the official listing in Annex VIIa of the Pharmaceutical Directive, to support their decisions regarding product substitution.

Importantly, if a prescribing physician has explicitly excluded substitution on medical or therapeutic grounds, pharmacies are not obliged to exchange the prescribed biologic. Furthermore, pharmacists have discretion to refrain from substitution if patient-specific considerations are evident. For example, if a patient has a documented history of adverse reactions, intolerance, or allergies related to a particular biosimilar, the pharmacist may choose not to perform the switch.

The new regulations are designed to balance the goals of maintaining drug safety and efficacy while supporting the sustainability of the healthcare system. They aim to increase the use of cost-effective biosimilars without compromising patient well-being or clinical outcomes.

The decision of the G-BA is now under review by the Federal Ministry of Health. Pending approval and publication in the Federal Gazette, the new rules are expected to come into effect no earlier than April 2026.

Stakeholders from various sectors, including pharmacists, prescribers, and industry representatives, will continue to monitor the implementation of these guidelines. The evolution of biosimilar use in Germany is anticipated to influence drug affordability, patient access, and the competitive landscape of the pharmaceutical market in the coming years.