Here at Pharmalicensing we are working alongside a very well established biopharmaceuticals company specialising in the development and manufacturing of biosimilars/biogenerics.
The company has a number of products in production and is now looking to partner its rhFSH substance to a suitable developer who could develop and commercialize it into a biosimilar to treat infertility.
The new biosimilar will be based upon Merck-Serono's Gonal-f® which is used in fertility treatments for ovulation induction (OI) and in vitro fertilization (IVF). The company has collected comparability data to Gonal-f®.
Suitable partners should have the financial, marketing and commercial capabilities to take this API through development and to the market. Companies should also have the know-how and expertise of biosimilars.
Potential partners would need to be responsible for the development of formulation, and multi-dose device (which can also be developed by the company upon agreed terms) and for the regulatory path and commercialization.