Recombinants versus biosimilars in ovarian stimulation

Abstract

Biosimilars, also known as follow-on biologics, are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Recombinant human follicle-stimulating hormone (r-hFSH) was one of the early biologic drugs to be approved and is used in assisted reproductive technologies (ART), sometimes known as in vitro fertilization. The drug was first marketed as Gonal-F by Merck Serono but has lost its European patent some time ago, US patent extends to 2015. In 2014, two FSH biosimilars obtained marketing authorization by the European Medicines Agency. Biosimilar FSH preparations are expected to be biologically and clinically "non inferior" to the originator product. However, prescribing a biosimilar to a patient calls for certain basic understanding by physicians of the scientific factors associated with the safety and efficacy of these products. Substituting an innovator brand by a biosimilar brand calls for caution in terms of quality, safety, and efficacy aspects due to clear differences between biosimilars and their reference products. The impact of FSH and human chorionic gonadotropn (hCG) biosimilars on cost and outcomes of ART is far from being established, since insufficient information is available to demonstrate the pros and cons in the long-term application.