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Review
. 2024 Aug 29;16(8):e68103.
doi: 10.7759/cureus.68103. eCollection 2024 Aug.

The Biosimilar Revolution: Assessing the European Union's Approach to Biosimilarity, Interchangeability, Patient Access, and Its Market Analysis

Gokul S  1 , Sudheer Kumar  1 , Kamaraj R  1
Affiliations
Review

The Biosimilar Revolution: Assessing the European Union's Approach to Biosimilarity, Interchangeability, Patient Access, and Its Market Analysis

Gokul S et al. Cureus. .

Abstract

The biosimilar revolution alters the biopharmaceutical environment, delivering an appropriate strategy for improving accessibility and cutting healthcare costs. The European Union (EU) has established a broad regulatory structure to ensure the proper and efficient use of biosimilars. This review examines the EU's approach to biosimilarity, interchangeability, and patient access, encompassing the legal framework, scientific considerations, market dynamics, and patient viewpoints. The EU's regulatory system has developed to accommodate biosimilar development, approval, and adoption difficulties. Biosimilarity involves demonstrating comparability to the reference product, whereas interchangeability necessitates a more nuanced approach. Patient access is affected by pricing, reimbursement, and education. Employing a mixed-methods approach, this review combines an evaluation of regulatory documents, scientific literature, and market survey analysis. This review looks at the accomplishments and obstacles of the EU's strategy, identifying areas for advancement and chances for further development. This review intends to give significant insights to stakeholders, such as policymakers, producers, medical professionals, and patients, by examining the EU's biosimilar revolution. This critique helps to shape initiatives to improve the EU's approach, boost patient access, and promote sustainable healthcare systems. Ultimately, this review demonstrates that the EU's approach to biosimilars has successfully increased market growth and suggested suitable areas for development.

Keywords: biosimilarity; biosimilars; eu regulatory framework; interchangeability; patient access.

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Conflict of interest statement

Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Approval of biosimilars in member states
This image was created by Mr. Gokul S.
Figure 2
Figure 2. European market growth analysis
This image was created by Mr. Gokul S.
See this image and copyright information in PMC

References

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