| Comprehensive physicochemical and biological nonclinical characterization of Ovaleap®, a recombinant human follicle-stimulating hormone to treat infertility and an approved biosimilar, demonstrated similar molecular characteristics and quality attributes to the reference medicinal product, Gonal-f®. |
| The Ovaleap® manufacturing process was found to be robust and reliable. |
| The Ovaleap® multidose application system was found to have long-term stability at ambient temperature, consistent with product labeling. |
Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.