Finox Biotech (Finox AG), a biopharmaceutical company, announced the Therapeutic Goods Administration (TGA), has granted a Marketing Authorisation (MA) for Bemfola (follitropin alfa solution for injection in pre-filled pens), the first follicle stimulating hormone biosimilar therapy used for the treatment of infertility. The TGA decision allows Finox Biotech to market Bemfola in Australia.

Bemfola is registered in Australia for the treatment of infertility in adult women and adult men. In adult women Bemfola is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated;- Controlled ovarian hyper stimulation in women undergoing assisted reproductive technologies;- Bemfola® in association with luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with serve LH and FSH deficiency. In clinical trials these patients were defined by endogenous serum LH level < 1.2 IU/l;- In adult Men Bemfola is indicated with the concomitant human chorionic gonadotropin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Gavin Jelic-Masterton, cief executive of Finox Biotech commented, “We are thrilled that the development of Bemfola has resulted in the Marketing Authorisation for Australia. We are confident that IVF Patients and Doctors across Australia will benefit from our commitment to quality, cost effectiveness and easy to use fertility medicines and that Bemfola will be a great success for our company’’.

Warren J. Jenkins, VP and general manager of Finox Biotech Pty Australia added, “This is the culmination of many years commitment to bringing a Swiss manufactured r-FSH to the market in Australia and I believe that with the cost effectiveness of the product and a pen designed to assist with patient compliance and ease of administration of Bemfola® will be very popular with physicians and patients”.

Bemfola was produced using recombinant DNA technology. Both Bemfola and the reference product GONAL-f are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. Bemfola is the result of a targeted drug development process aimed to replicate as closely as possible the reference product. The brief to the development engineers when designing the Bemfola injector device was to produce a Pen that minimised the number of steps a patient needs to take when preparing the injection and to ensure that the patient and physician had maximum control and the least chance of a patient error. The result, the Bemfola Pen, is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject.

Finox Biotech has agreed with the US FDA to conduct a pivotal phase III study (FIN3002) for registration of Bemfola (Afolia) in the USA. A US-IND has been opened and the FIN3002 study is now in progress.