[Revised version of the statement by the DGRh on biosimilars-update 2017]

Area of Science:

• Rheumatology
• Pharmacology
• Health Economics

Background:

• Biologic therapies have transformed rheumatic disease treatment.
• Patent expirations allow for the introduction of biosimilars.
• Biosimilars require rigorous comparability assessments for approval.

Purpose of the Study:

• To review the current landscape and impact of biosimilars in rheumatology.
• To discuss the implications of biosimilar availability on patient access and healthcare costs.
• To examine the safety and efficacy of switching between originator biologics and biosimilars.

Main Methods:

• Review of regulatory requirements for biosimilar approval (EMA, FDA).
• Analysis of biosimilar market entry and pricing trends in Germany and globally.
• Evaluation of data on biosimilar switching (interchangeability and substitution) from clinical studies and registries.

Main Results:

• Multiple biosimilars for infliximab, adalimumab, etanercept, and rituximab are approved and available.
• Biosimilars have led to price reductions for originator biologics and decreased healthcare spending in Germany.
• Preliminary data from Norway and Denmark suggest substitution with biosimilars does not introduce new safety issues.

Conclusions:

• Biosimilars enhance the availability and affordability of biologic treatments for inflammatory rheumatic diseases.
• While beneficial for cost containment, the German Society for Rheumatology recommends shared decision-making between physicians and patients for biosimilar use.
• Further research and long-term data will continue to support the safe and effective integration of biosimilars into rheumatology practice.