RhFSH Drug Substance, Highly Similar to Gonal-F®, Requiring Further Development Into Biosimilar to be Used in Fertility Treatments
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Abstract ID:
A biosimilar specialist has manufactured the rhFSH API and is now looking for a partner to fully develop it into a biosimilar comparable to that of Gonal-f®
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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.

Type of Business Relationship Sought
The client would ideally like a co-development agreement with a suitable life science company, but would consider other partnerships too following discussions.
Last Updated May 2017
Technology Type RESEARCH
Phase of Development EARLY STAGE
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