G-BA Adds REMSIMA Liquid to Infliximab Price Cap Group

Infliximab reimbursement in Germany now incorporates a newly approved liquid concentrate of infliximab into an established fixed-amount cluster under statutory health insurance rules. This change ensures uniform GKV payments across dosage forms without special pediatric provisions, following the absence of objections in consultation and confirmation that § 35 SGB V criteria are met.

Infliximab Reimbursement Germany Framework

The Gemeinsamer Bundesausschuss (G-BA) decision integrates the 350 mg liquid presentation directly into the cluster previously reserved for powder formulations. By applying the actual active-substance quantity per unit as the reference metric, the authority equates the new vial with existing 100 mg powder units under § 35 Absatz 3 SGB V. This approach avoids separate classification for age-specific strengths, even though the product holds authorization for patients from age six onward. The resolution affirms the pharmacological comparability of both forms, reflecting established regulatory practice for biosimilar groups.

GKV Pricing and Market Implications for Infliximab

Incorporating the new concentrate into the Festbetragsgruppe aligns it with the 710 EUR fixed-amount reference for a single 100 mg powder pack. This constrains effective reimbursement for the 350 mg vial priced at 2,404.64 EUR (pharmacy retail price) against a statutory ceiling derived from the 100 mg unit ratio. Manufacturers unwilling to reduce prices to the fixed-amount level may see patients bear supplementary copayments beyond standard statutory contributions. The absence of stakeholder objections during consultation suggests industry acceptance of the categorisation.

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Regulatory Process and Biosimilar Implications

The G-BA convened its medicinal products subcommittee in March 2026 to review the update, formally adopting the consultation process in the same session. The absence of written responses in the subsequent consultation reinforced the final resolution adopted by the full committee in June 2026. Infliximab biosimilars, including REMSIMA by Celltrion Healthcare, now face uniform reimbursement conditions for both powder and concentrate forms in Germany. This administrative alignment may support payer cost-containment goals while encouraging therapeutic interchangeability across formulations.