Teva launches biosimilar fertility treatment in the UK
pharmafile | January 8, 2016 | News story | Manufacturing and Production, Sales and Marketing | Ovaleap, Teva, biosimilar
Teva has launched its biosimilar version of Merck’s fertility treatment Gonal-f in the UK, potentially bringing a more affordable version of the therapy to the one in seven couples facing conception challenges in the country.
Ovaleap (follitropin alfa, r-hFSH) is a fertility treatment for anovulation, stimulation of follicular development and spermatogenesis.
The product, which the EMA approved in September 2013, is a copycat version which has the same indication and a comparable efficacy and safety profile to Merck’s original reference product. Ovaleap is administered via a re-useable self-injection pen, which can hold three different cartridge sizes to deliver the active ingredient, follitropin alfa –a copy of the natural hormone FSH, which controls reproductive function in men and women.
It treats women who do not produce eggs and have low levels of luteinising hormone (LH) and follicle stimulating hormone (FSH), as well as men with the rare hormone deficiency disease hypogonadotrophic hypogonadism, which affects sperm production.
Ovaleap has demonstrated therapeutic equivalence with Gonal-f in clinical trials, including a Phase III study of 299 infertile women undergoing IVF. Studies found no difference between the two treatments in the number or quality of eggs retrieved from the ovaries, or in the number of babies born.
Christophe Pelletier, vice president of women’s health in the Europe division of Teva, the world’s largest generic manufacturer, says: “As a leading global pharmaceutical company that delivers patient-centric healthcare solutions to millions of people every day, we hope that by providing a r-hFSH alternative, more people facing infertility will be able to access and benefit from treatment.”
Joel Levy
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