Biosimilars or biosimilar medicines can be developed as a copy of original, reference biological drug, after the market protection of the reference product has expired, and approved for use in all indications for which the reference product is approved. Potential candidates gain biosimilars status by demostrating a very similar profile to the reference medicine in a series of comparative quality, non-clinical and clinical trials. The volume of the trials required is determined, and consequently the scientific certification of a biosimilar is given by the regulative medical agencies, first and foremost by the European Medical Agency as a leader in this field, followed by the market approval of the Applicant which is carried out by the European Commission. In the field of human reproduction two biosimilars of follitropin alfa are currently approved, which are used as stimulants of multifollicular development in controlled ovarian hyperstimulation for the purposes of assisted reproductive technology, among several indications. In pre-clinical studies, differences in the structure of biosimilars to the reference follitropin alfa (Gonal-f) were observed, thoroughly researched, documented and considered acceptable according to the concept of biosimilarity. These differences did not show any influence on the biological activity examined in in vitro and in vivo studies. Phase I clinical trials have demonstrated the bioequivalence of the pharmacokinetic profiles of both biosimilars according to the reference follitropin alfa (Gonal-f) in a group of healthy voluntary women. Finally, Phase III clinical trials have demonstrated comparable therapeutic efficacy of biosimilars and the reference follitropin alfa by primary endpoint, the number of retrieved oocytes, and comparability of secondary endpoints as well as a comparable adverse event profile in women undergoing controlled ovarian hyperstimulation for the treatment of assisted reproductive technology. The primary purpose of developing biosimilars, due to the potentially shorter production process, is to lower the price of biological therapies when bidding on biosimilars with original products. However, biosimilars of follitropin alfa have had a smaller impact on the cost and volume of use of recombinant follitropin in Europe, and available pharmacoeconomic analyses have not shown that complete treatment cycles of assisted reproductive technology using biosimilars lead to real cost-savings for healthcare system stakeholders.