Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get?. Issue 8 (August 2022)

• Record Type: Journal Article
• Authors: de Mora, Fernando; Howles, Colin M.
• Is Part Of: Drug discovery today. Volume 27:Issue 8(2022)
• Page Start: 2071
• Page End: 2075
• Publication Date: 2022-08
• Subjects: Bemfola® -- Biosimilar -- Follitropin alfa -- Gonal-f® -- Ovaleap® -- Recombinant follicle-stimulating hormone -- Reproductive medicine -- rFSH -- Follitropin beta; Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2022.04.022
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Biosimilars are not identical to Gonal-f® in as much as Gonal-f® is not identical to itself. Irrelevant clinical differences between biosimilars and Gonal-f® are not medicines-related. Real-world evidence confirms that Ovaleap® (from Theramex UK Ltd) and Bemfola® (from Gedeon Richter Plc) are same-quality replacements for Gonal-f® (from Merck Serono). Unfounded skepticism relating to rFSH biosimilar preparations incurs a high opportunity cost for patients. Abstract: Unfounded skepticism relating to biosimilars, arising from the assertion that they are not molecularly identical to their original counterpart, fails to acknowledge that no biological medicine, including Gonal-f® (from Merck Serono) is identical to itself. Molecular differences between the biosimilar and the reference medicines are irrelevant and clinically undetectable as long as they are contained within the accepted variability for the original medicine. Accordingly, the minor differences in 'ongoing pregnancy rate' and 'live birth' rate reported in a recent meta-analysis of biosimilars of Gonal-f® from Chua et al. are probably driven by product-unrelated factors, notwithstanding the fact that of the four products under analysis, only Ovaleap® (from Theramex UK Ltd) and Bemfola® (from Gedeon Richter Plc) can unambiguously be considered to be biosimilars. The EU Biosimilars model has proven successful, but some healthcare professionals, building on highly arguable premises, voice a distrust in biosimilars. Only if such scientifically unfounded distrust is reverted, the full promise of rFSH alfa biosimilars for reproductive medicine patients is likely to be fulfilled.