Biosimilars and access to biologic therapy in immune-mediated diseases

ABSTRACT

Background

The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability’s impact on biologic therapy access for IMIDs.

Research design and methods

A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed.

Results

267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions.

Conclusion

The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals’ therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.

KEYWORDS:

• Immune-mediated
• biosimilar
• availability
• access
• biologic
• originator

Declaration of interest

This work pertains to a non-commercial observational study independently promoted by the Spanish Foundation of Hospital Pharmacy (FEFH). FEFH is a nonprofit scientific entity that integrates specialized hospital pharmacists in Spain. All authors of the study are affiliated with this organization but do not have any financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was approved by the Ethics Committee of the Canary Islands University Hospital on 28 October 2021 (approval code: BEIIPAC). According to the study protocol approved by the CEIM, the study complies with the requirements of Article 5 regarding informed consent and protection of personal data of participating subjects, as outlined in Royal Decree 957/2020. Since this is a retrospective study, it is not necessary to obtain consent from patients for the processing of their data. Despite not being collected directly from the individuals, the purpose of the data is solely statistical and scientific, thus exempting the need for patient consent.

In all contracts signed between the FEFH and hospital authorities, explicit authorization is given for data access, processing, and publication of study results. Spanish privacy legislation (Organic Law 3/2020) and observational study regulations (Royal Decree 957/2020) require the promoter and responsible parties to sign contracts that establish all guarantees, security measures, and permissions for data access, processing, use, and publication of research study results. These obligations have been fulfilled by all participating centers in the study, providing legal coverage for the use of patient data.

Author contributions

R Vázquez-Sánchez has written the article, having substantially contributed to its drafting and revision. M Navarro-Dávila has substantially revised the article and has actively participated in data collection and patient recruitment as a principal investigator. E Ramirez Herráiz, J Borrás-Blasco, V Merino-Bohórquez, A Onteniente-González and A Iglesias-Lambarri have reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. Additionally, they have actively participated in data collection and patient recruitment as principal investigators. E Negro-Vega has reviewed and approved all versions of the manuscript before submission, during the revision process, the final version accepted for publication, and any significant changes made during the proofing stage.

Acknowledgments

The abstract of this paper was submitted to the 68th National Congress of the Spanish Society of Hospital Pharmacists (SEFH), held in Bilbao in October 2023.

Conflict of interest statement

The authors have no conflicts of interest to declare.

Additional information

Funding

This paper was funded by the Spanish Hospital Pharmacy Foundation under the Framework Collaboration Agreement concluded in 2021 between the Spanish Society of Hospital Pharmacists and the Spanish Association of Biosimilar Drugs.