operations
REGULATORY AFFAIRS
GeneMedix will initially strive to gain marketing approval in territories where patents have expired or never existed.
Our aim is to register our products in the EU, where the legal and regulatory pathway for our main products have been set, but where there still remain some hurdles to the market authorisation of biosimilars. We are also ultimately aiming at registering our products in the US once patents have expired and the legal and regulatory pathway are in place. To achieve our aims, we are working proactively with the relevant regulatory authorities, and through our close links with the European Generic medicines Association [EGA].
We have formulated a robust clinical strategy that we believe will provide scientific evidence that our products are comparable to those already marketed. We strongly believe that the studies we intend to perform, and the dossiers we submit, will clearly demonstrate comparability with the currently marketed product.
In addition, we have been in discussions with regulatory authorities in China, India and Malaysia, and have established the regulatory requirements for gaining product approvals in these territories.
Further information on Comparable Biotechnology Products can be obtained from the EGA website.