Manufacturing of Recombinant Human Follicle-Stimulating Hormone Ovaleap ® (XM17), Comparability with Gonal-f ® , and Performance/Consistency.

Ovaleap® (XM17) is a recombinant human follicle-stimulating hormone to treat infertility by inducing ovulation or controlled ovarian stimulation for assisted reproductive technology (ART) procedures. Ovaleap® (follitropin-α) was approved by the European Medicines Agency in 2013 as a biosimilar medicinal product to the reference medicine, Gonal-f® . Information is often not easily accessible and/or publicly available regarding the rigorous manufacturing procedures for biosimilars. Objectives of the current analysis were to report on validation procedures for the Ovaleap® manufacturing process, to compare the characteristics of Ovaleap® versus Gonal-f® , and to describe the performance and consistency of Ovaleap® . Formal validation of the Ovaleap® manufacturing process was performed at full commercial scale, consisting of several consecutive fermentation and purification runs. Comparison with Gonal-f® involved numerous techniques to determine molecular structure, isoform distribution, biological activity, and product-related impurities. The stability of the multidose application system, targeted for long-term stability at ambient temperature, was assessed and demonstrated. All analyses showed the manufacturing process of Ovaleap® to be robust and consistent. Ovaleap® was found to have similar characteristics when compared with Gonal-f® . This analysis supports the role of Ovaleap® as a biosimilar to Gonal-f® , thus providing patients and clinicians with another therapeutic option during ART procedures.