Biosimilar Substitution in Germany: Sections 40b and 40c

Germany now allows pharmacies to substitute a prescribed biologic with a lower-cost biological medicine at the point of dispensing, governed by two additions to Annex VIIa of the Arzneimittel-Richtlinie: Section 40b, in force since 15 March 2024, covers parenteral preparations compounded from finished medicinal products, and Section 40c, in force since 1 April 2026, extends the same logic to biological finished medicinal products handed directly to patients. Both rest on the same legal basis in Section 129 SGB V and the same reference resource, the biologic-to-biosimilar groupings in Annex VIIa. A pharmacy substitutes only within a defined equivalence corridor, and the prescriber can rule substitution out. The measurable consequence has been price: biosimilar and reference biologic list prices moved sharply in the weeks around the Section 40c start date.

This article is written for market access, regulatory affairs and pharmaceutical trade professionals outside Germany who need to understand what automatic biosimilar substitution means in practice, what the two paragraphs actually require, and how the price effect propagates. It is not medical advice.

What changed, and on which dates?

Germany reached pharmacy-level biosimilar substitution in stages, and the staging is the substance of the story. The scientific case for interchangeability was settled at EU level first. In a joint statement of 19 September 2022, the European Medicines Agency and the Heads of Medicines Agencies confirmed that biosimilars approved in the EU are interchangeable with their reference medicine or with an equivalent biosimilar. That statement was explicit that it does not itself authorise pharmacy-level substitution, which each Member State decides for itself.

Germany decided through Section 129 SGB V. The statute directs the Gemeinsamer Bundesausschuss (G-BA) to issue interchangeability guidance, first for prescribers by 16 August 2020, then for pharmacy-level substitution, beginning with parenteral preparations. The G-BA then translated that mandate into the two operative paragraphs of Annex VIIa. The table sets them side by side.

The G-BA has confirmed that the earlier Section 40b rules for parenteral preparations, applied since 15 March 2024, remain in place unchanged, and that Section 40c takes effect on 1 April 2026 following approval by the Federal Ministry of Health. The two paragraphs are cumulative, not a replacement.

How does pharmacy substitution work under Section 40c?

Substitution is not a free choice between any biologic and any biosimilar. It happens inside a tightly drawn equivalence corridor, and the corridor is what keeps the swap clinically defensible. Per the G-BA rules for Section 40c, the product dispensed must match the prescribed product on every one of the following before a swap is permitted.

• Active strength. Identical Wirkstärke, not merely the same active substance.
• Pack size. Identical Packungsgröße.
• Dosage form. The same or an interchangeable Darreichungsform.
• Container. For products of the same dosage form, the container must match, so a pre-filled syringe is not substituted by a pre-filled pen or a cartridge.
• Indication. Approval for at least one identical indication.
• Route of administration. At least the same routes of administration as the prescribed product.

Within that corridor, selection is ordered, not discretionary. A rebate-contract product between the patient's sickness fund and a manufacturer takes precedence, and where no rebate contract applies, the pharmacy dispenses the most economical option available under the framework agreement. Which product is correct therefore depends on the patient's insurer, exactly as it does for generic aut-idem substitution.

The prescriber retains control. If the physician has ruled out substitution for the individual patient on medical or therapeutic grounds, by marking the prescription accordingly, the pharmacy is not obliged to substitute and dispenses as written. Annex VIIa itself is the information source pharmacies consult to see which biologics and biosimilars the G-BA has grouped as interchangeable. The full text of the change is documented in the G-BA resolution establishing Section 40c.

Why did Section 40b come first?

Sequencing parenteral preparations ahead of finished medicinal products was deliberate. Compounded infusion and injection solutions, the Section 40b scope, are prepared by specialist pharmacies for direct administration, frequently in oncology. The volumes are concentrated, the pharmacies are sophisticated, and the substitution decision sits with a compounding professional rather than at a busy retail counter. Starting there let the mechanism run for two years on lower-frequency, higher-value products before Section 40c extended it to the far larger population of self-administered biologics in pens and pre-filled syringes.

The statutory logic in Section 129 SGB V mirrors this. The pharmacy-substitution mandate was written to begin with parenteral preparations compounded from finished medicinal products for direct administration, then to widen. The full statute is published at gesetze-im-internet.de. BfArM, for its part, sets out the underlying science, stating that biosimilars approved in the EU are interchangeable from a scientific viewpoint while leaving the pharmacy-substitution decision to the Member State.

What is the price effect on biologics?

The purpose of substitution is competition, and the clearest signal is in the list prices. The figures below are pharmazie.com first-party data drawn from Pharmonitor, our market observation of German biologic and biosimilar pricing, measured around the 1 April 2026 start of Section 40c. They are list-price movements, not net prices after rebate.

• Anticipation phase, 1 September 2025 to 1 April 2026. Over these seven months, biosimilar list prices fell by an unweighted average of 11.7 percent. Reference biologics fell 5.7 percent, with 92 percent of reference products declining.
• Activation phase, 1 to 15 April 2026. In the first two weeks under Section 40c, biosimilar list prices fell a further 6.9 percent, and reference biologics 3.5 percent, with 97 percent of reference products changing price.
• Acceleration. The monthly rate of price change in the activation phase was roughly nine times the rate in the anticipation phase. The rule did not merely lower prices, it steepened the slope.
• Filgrastim as an example. Among G-CSF products, biosimilar filgrastim fell around 27 percent in the anticipation phase, while the reference product fell around 50 percent, a case where the originator cut harder than the biosimilars to defend its position.

On the fiscal scale of the policy, the Wissenschaftliches Institut der AOK (WIdO) has estimated the annual savings potential from mandatory biosimilar use at up to 2.33 billion EUR. That figure is a third-party estimate attributed to WIdO, not a pharmazie.com measurement, and it describes potential rather than realised savings. The direction of both the first-party price data and the third-party estimate is the same: substitution transfers value from originators to payers, and it does so faster once the pharmacy-level obligation is live.

How does the substitution question reconcile in the data?

Every element of a Section 40c decision has to be answered at article level, and in Germany the article-level key is the Pharmazentralnummer (PZN). Whether two products share an active strength, a pack size, a dosage form and a container, whether either carries a rebate contract, and which is the most economical eligible option, are all attributes of specific PZNs, not of a substance in the abstract. A substitution engine that reasons at substance or product level cannot answer the question the pharmacy is actually asked.

This is where a consolidated data source earns its place. pharmazie.com carries the biologic-to-biosimilar reference mapping, substitution eligibility flags aligned to Annex VIIa, and the price, rebate and reimbursement context for each PZN, alongside the ABDA-Artikelstamm, and exposes them through a REST API and structured data export. That lets a pharmacy, ERP or e-prescribing system evaluate the equivalence corridor programmatically rather than by manual lookup. To be precise about scope: this is a data and mapping layer keyed on the PZN, not a claim to determine the dispensing decision or to replace the G-BA resolution, which remains the legal authority. The reimbursement context that sits behind these prices, including AMNOG-negotiated amounts, is covered in our AMNOG reimbursement database overview, and the wider mechanics of German list and net pricing in our guide to pharma pricing in Germany.

What does this mean for market access teams outside Germany?

For an international market access or trade team, Section 40c changes three things at once. First, the German biosimilar opportunity is no longer gated by prescriber behaviour alone, because the pharmacy now completes the switch within the equivalence corridor, which raises effective biosimilar uptake for eligible products. Second, originator list prices are under measurable downward pressure in the weeks around the start date, so launch and defence pricing has to be modelled against a steeper curve than the pre-2026 pattern suggests. Third, the corridor conditions, active strength, pack size, dosage form, container, indication and route, decide whether a given presentation is even substitutable, which turns pack and device strategy into a market access lever rather than a packaging detail.

None of this is legible from a single national clinical database or a single price file. It requires the biologic-to-biosimilar mapping, the article-level attributes and the rebate and reimbursement context to be queried together, on the same key, for the same PZN. That reconciliation is the work, and it is the work whether you are a payer estimating savings, an originator defending a franchise, or a wholesaler sourcing the eligible product.

This content is intended for healthcare professionals and does not constitute medical or legal advice. Legal status described as of July 2026. Last reviewed: July 2026.