Follow-on Biologics

Follow-on biologics are not generic drugs. A generic drug is a product that is shown to be the same as an innovative drug, and is generally designated as therapeutically interchangeable with the innovator drug. Unlike generic drugs, a follow-on biologic (or "biosimilar") is a product that is similar to, but not the same as, the innovator drug. Because of the complex science involved, the Food and Drug Administration (FDA) and foreign regulators have indicated that the generic drug approval pathway is not appropriate for complex biologics.

We are interested to acquire production technologies of therapeutic monoclonal antibodies, such as Rituximab and Infliximab. Our client is an established Russian company looking to increase its product portfolio by in-licensing or acquiring new products. Our client has extensive experience with in-licensing into Russai, the company is able to tender products to the Russian government as well as launch products on the private market. Our client has sales and distribution networks in place and is able to re-label products for the Russian/CIS market.