Safety profiles of biosimilars vs. their EU reference products: INNs (adalimumab, bevacizumab, trastuzumab, rituximab, infliximab, etanercept)

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This study evaluates the safety profiles of biosimilar medicinal products (MPs) compared to their reference counterparts within the European Union (EU). Biosimilars, cost-effective alternatives to original biologics, enhance patient access to vital treatments. Despite their similarity to reference products, nuanced differences necessitate rigorous pharmacovigilance. Between April 2006 and November 2022, 73 biosimilars (81%) received EU marketing authorization (MA), 15 (17%) were authorized but later withdrawn, and 2 (2%) had MAs rejected. Notably, none of the 90 biosimilars were withdrawn or rejected for safety reasons, underscoring the EU’s stringent drug evaluation and monitoring processes. Our research analyzed six international non-proprietary names (INNs): adalimumab, bevacizumab, trastuzumab, rituximab, infliximab, and etanercept, using European Public Assessment Reports (EPARs), Risk Management Plan (RMP) summaries, and EudraVigilance (EV) data. Of 30 analyzed adverse drug reaction (ADR) groups, 70% showed minor deviations (0 to ±10%) between biosimilars and reference products. 17% of the groups were in the ±10 to ±20% range of difference, and only 13% of the ADR groups were in the range of difference above ±20%. The findings demonstrate consistent regulatory approaches, with biosimilars sharing indications and safety risk profiles with their reference products, supporting extrapolation principles in approvals. However, transparency challenges persist in comparing publicly available safety information between biosimilars and reference products. This study highlights the EU’s robust regulatory framework ensuring biosimilar safety and efficacy, supporting their therapeutic integration. Long-term observations remain crucial to validate data, build trust, and emphasize interchangeability among biologics and biosimilars.