Biosimilars of Adalimumab In Eu: Addressing Regulatory Barriers and Market Dynamics to Enhance Accessibility and Affordability

Abstract

The research examined regulatory obstacles together with market dynamics which affect EU adalimumab biosimilars adoption to enhance their market availability and economic value. The research examined regulatory variations together with market elements and pricing systems and stakeholder perspectives to create evidence-based solutions. A quantitative survey method served as the research methodology to gather data from healthcare professionals and policymakers and patient representatives across multiple EU member states. SPSS analysis of data included descriptive statistics as well as correlation and regression techniques.

The European Medicines Agency (EMA) centralised approval did not eliminate significant regulatory fragmentation. National policies regarding substitution practices together with reimbursement systems and procurement procedures determine how much biosimilar market adoption will take place. Germany and France showed high biosimilar adoption because their substitution and reimbursement policies were supportive yet Italy and Spain and Bulgaria showed slow adoption because their policies were restrictive and procurement systems were limited. The market dynamics played a significant role in biosimilar adoption because both transparent competitive tendering and originator companies' aggressive discounting and single-supplier contracts affected market competition.

Stakeholder opinions regarding biosimilars were influenced by knowledge deficits alongside safety concerns and patient unwillingness to transition from original products. The substitution policy and sustainable pricing strategies emerged as the leading determinants of EU policy harmonisation support according to the correlation analysis. The regression analysis showed that regulatory and market and stakeholder-related factors explain 28.1% of the variance in support for harmonisation indicating multiple barriers to adoption exist.

The study demonstrates that EU-wide standardised substitution and reimbursement systems combined with clear procurement methods and targeted educational initiatives for stakeholders will drive biosimilar acceptance by promoting trust and comprehension. The study advises that policy alignment should be supported while long-term multisupplier contracts should be established and savings from cost reduction should fund patient care and structured switching protocols with effective communication should be created.

The economic and accessibility benefits of EU adalimumab biosimilars depend on solving fragmented regulations and market inefficiencies. The EU will create a sustainable biosimilar market with universal access through unified policy reforms combined with stakeholder education and member state cooperation. The proposed method would reduce healthcare costs while extending access to treatment for patients suffering from chronic inflammatory conditions