Biosimilar recombinant follicle stimulating hormones in infertility treatment

Abstract

Introduction: Follicle stimulating hormone (FSH) is a glycoprotein hormone essential for reproduction both in females and males and it is physiologically produced by the anterior pituitary gland in several isoforms. This heterogeneity is typical also of FSH-containing compounds, both urinary-derived and recombinant products. These compounds are widely used in assisted reproductive technologies (ART), to induce multifollicular development. Recently, the increased cost pressure on healthcare systems and the patent expiration date of widely used biotechnology-derived, recombinant FSH, prompted the pharmaceutical interest in FSH biosimilars.

Areas covered: In 2014, two FSH biosimilars obtained marketing authorization by the European Medicines Agency. Here, we review the biology of natural, extractive and recombinant FSH, the current state of biosimilar FSH, including the legal framework, and aspects to be considered in biosimilar FSH usage. Literature search methodologies included Medline and PubMed research.

Expert opinion: Biosimilar FSH preparations are expected to be biologically and clinically ‘non inferior’ to the originator product. However, the impact of FSH 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.

Keywords::

• biosimilar
• follicle stimulating hormone
• gonadotropins
• recombinant follicle stimulating hormone

Declaration of interests

This work was partially supported by the Italian ministry of University and Research (PRIN nr. 2010C8ERKX) to M Simoni. D Santi is PhD candidate of the Doctorate School in Clinical and Experimental Medicine of the University of Modena and Reggio Emilia. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

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