Saturday, June 15, 2024

New Update on Biologics and Biosimilars in Germany

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The Joint Federal Committee (G-BA) has made significant amendments to the Drug Directive (AM-RL) Annex VIIa concerning biologics and biosimilars. This update aligns with the Act for More Safety in the Supply of Medicines (GSAV) which took effect on August 15, 2019.

According to Section 129, Paragraph 1a, Sentence 3 of the Fifth Book of the Social Code (SGB V), the G-BA is tasked with providing guidelines on the interchangeability of biological reference medicinal products with essentially similar biotechnologically produced biological medicinal products. This regulation aims to ensure therapeutic comparability and guide their interchangeability by physicians and pharmacies.

The GKV Financial Stabilization Act (GKV-FinStG), effective from November 12, 2022, expanded this mandate, requiring initial guidelines for the interchangeability of parenteral preparations from finished medicinal products for immediate medical use by patients. To execute this mandate, the G-BA can access the approval documents from the competent federal authority as per Section 129, Paragraph 1a, Sentence 7 SGB V. These amendments in Annex VIIa were made through a consensus decision by the G-BA subcommittee.

G-BA Updates Guidelines for Biologics and Biosimilars

The G-BA has implemented Section 40a in the AM-RL and added Annex VIIa, which includes information on the approval status of biologics and their biosimilars. Initially adopted on November 19, 2021, Annex VIIa has been updated to include guidelines for parenteral preparations. This update ensures that pharmacies have the necessary information to verify the prerequisites for substituting prescribed biotechnologically produced finished medicinal products with parenteral preparations.

The decision updates the guidelines on the interchangeability of biological reference medicinal products for medical prescriptions and for replacing prescribed biotechnologically produced finished medicinal products with parenteral preparations by pharmacies in Annex VIIa to the AM-RL. These updates are based on the approval documents, and the G-BA obtains access to these documents from the competent federal authority as per Section 129, Paragraph 1a, Sentence 7 SGB V.

The proposed decision does not create any new or changed information obligations for service providers, resulting in no bureaucratic costs. The update to Annex VIIa was discussed by a working group consisting of members appointed by the leading organizations of service providers, the GKV-Spitzenverband, and representatives of patient organizations.

The draft resolution to initiate a consultation process was agreed upon in the subcommittee meeting on February 6, 2024. No written comments were received during the consultation process, and thus no oral hearing was required. The final decision to update Annex VIIa to the AM-RL was agreed upon on March 26, 2024.

biosimilars

In accordance with Section 92, Paragraph 3a SGB V, the consultation process involved seeking comments from experts in medical and pharmaceutical sciences and practice, as well as relevant organizations representing the pharmaceutical industry, pharmacists, and doctors’ associations. No comments were received during the written consultation process.

The G-BA determined that the approval relationships for the active ingredient Bevacizumab have changed. The approval for the drug “Onbevzi” was withdrawn at the request of the manufacturer. This change is reflected in Annex VIIa (Biologics and Biosimilars) to the AM-RL, removing “Onbevzi” from the list of biosimilars for Bevacizumab.

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For Bevacizumab, the original/reference medicinal product (Avastin) and its biosimilars (Abevmy, Alymsys, Aybintio, Mvasi, Oyavas, Vegzelma, and Zirabev) are approved based on Article 10, Paragraph 4 of Directive 2001/83/EC.

The G-BA’s update to Annex VIIa of the Drug Directive reflects the latest changes in the approval status of biologics and biosimilars, ensuring that healthcare providers have up-to-date information for prescribing and substituting these medicines. This update supports the safe and effective use of biologics and biosimilars, benefiting patients and the healthcare system.

 

 

Resource:  Gemeinsame Bundesausschuss, May 27, 2024

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