SAFETY AND CLINICAL EFFICACY IN BIOSIMILAR SUBSTITUTION

Revista Portuguesa de Farmacoterapia

João Pedro Fernandes¹  João Gonçalves² 

[1] Faculdade de Farmácia da Universidade de Lisboa;PhD, Faculdade de Farmácia da Universidade de Lisboa;

关键词: Biosimilar;    switch;    interchangeability;    immunogenicity;    safety.;   

DOI  :  

来源: DOAJ

【 摘 要 】

Biosimilar medicinal products have become a reality in recent years. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing regulatory guidance on data requirements for their development and approval, many clinicians are still reluctant to consider biosimilars as a treatment option for their patients. Moreover, the approval of biosimilars has prompted the discussion of whether these products can be safely switched with the innovator biopharmaceuticals without a negative impact on the efficacy of the treatment or an increased risk of immunogenicity. This review gives an overview of the available data related to the switch between an originator product and a biosimilar. A search was conducted for pre- and post-approval clinical studies involving patients that were switched between innovator drugs and EMA approved biosimilars. Currently, there is limited clinical data that specifically investigates the effects of switching. Nevertheless, the data analyzed from clinical studies reporting on switching between originator products and their respective biosimilars indicates that switching has no impact on the efficacy, safety and immunogenicity of treatment in patients.

【 授权许可】

Unknown