biosimilar switching
Insider Insights

Biosimilar Switching in Germany from March 15, 2024


Pharmacies will be required to adhere to the regulations on biosimilar switching outlined in the new Section 40b of the Medicines Directive starting March 15, 2024. This directive addresses the interchangeability of finished medicinal products containing biotechnologically produced active ingredients, as prescribed by physicians. The Federal Joint Committee (G-BA) resolution, published today in the Federal Gazette, will come into effect on March 15, 2024.

According to the new guidelines, pharmacies should select the most cost-effective product based on the active ingredient. If a medication is included in a discount agreement with the patient’s health insurance company and is considered cost-effective, pharmacies do not need to conduct additional cost comparisons. However, if there is no discount agreement in place, pharmacies are typically required to follow the guidelines outlined in the auxiliary tax regulations.

One of the main requirements for replacing a product with a more economical option is ensuring that the prescribed medication matches the final product prepared by the pharmacy, particularly in terms of how it is administered. Additionally, agreement must be reached regarding the specific applications of the prescribed medication. Substitution is permissible between a reference medication and its biosimilars, as well as amongst different biosimilars. Pharmacies can consult Appendix VIIa of the Medicines Directive for guidance on substitution decisions, as it outlines the relationships between approved biologics and their biosimilars in Germany.

However, if the physician has explicitly ruled out substitution of the prescribed biologic for medical or therapeutic reasons, the pharmacy is no longer obligated to make the substitution. Additionally, pharmacies may opt out of substitution considering patient-specific factors, such as known side effects, intolerances, or allergies experienced by the patient in the past.

So what does this mean?

These regulations aim to promote cost efficiency by requiring pharmacies to choose the most cost-effective product, prioritising options covered by discount agreements from patients’ health insurance companies. Clients with biologics may experience a sales decline, especially when launching into a market where biosimilars are emerging as potential comparators, necessitating competitive pricing strategies for their products. Conversely, clients with biosimilars already in their portfolio may benefit from this regulatory environment, potentially leading to increased sales or market share.

Have you read our other insights on market access in Germany?


Biologics preparations: From 15 March, information on interchangeability in pharmacies will apply – Federal Joint Committee (

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