(12) A Regulatory Overview of Biosimilars Across Selected Countries

Publication Number: 1057

Background: Biosimilars are biological medicines highly similar to a reference biotherapeutic product. The marketing approval of biosimilars is expected to reduce health care spending and improve access to biological products. Although most of the regulatory authorities follows the World Health Organization guidelines for the approval of biosimilars, regulatory pathways and evidence to achieve marketing authorization may differ between countries.

Objectives: The study aimed to perform a cross-national comparison of the regulatory approval of biosimilars

Methods: A cross-sectional study was conducted involving researchers from Argentina, Australia, Brazil, Chile, Colombia, Guatemala, Italy, Mexico and the United States. The data collection form was developed to investigate publicly available information on the national regulatory processes for biosimilars approval and included the names of biosimilars/reference products, manufacturing company, year of approval, therapeutic indications, extrapolation of indications, available clinical trials compared to the reference product and use of real-world evidence (RWE) in the approval process. The collected information was analyzed through descriptive statistics

Results: Two hundred and fifty-six biosimilars were identified, with the highest number reported by Italy (67) and Brazil (41). From 2017 to 2019, the biosimilars approvals peaked in most of the countries. The immunosuppressants and the antineoplastic agents were the only therapeutic classes approved in all the studied countries. Adalimumab and trastuzumab and were the most frequently approved products with up to nine and six brands names authorized in the same country, respectively. The assessment reports were not publicly available in all countries. Most biosimilars authorizations accepted extrapolation of therapeutic indications. Once marketed, line extensions were uncommon. National regulatory authorities did not report use of RWE in the biosimilars approval process.

Conclusions: Despite the increase in the number of approvals in the last years, the study revealed differences in the quantity and therapeutic classes of biosimilars approved across different countries. Generally, biosimilars were approved with extrapolation of indications and, as a consequence, further line extensions were not needed