As patent cliff looms, collaborations for mAB biosimilars are born
Budapest/Bad Vilbel – Hungarian drug maker Gedeon Richter plc and German STADA Arzneimittel AG have signed two separate licensing and marketing contracts to develop biosimilar versions of the monoclonal antibody drugs Rituximab and Trastuzumab.
Under the terms of the first agreement,
STADA has received non-exclusive distribution rights from Gedeon Richter for a biosimilar mimicking Roche’s blockbuster rituximab against arthritis and diverse cancers, which had European sales of around €1.15bn last year. The antibody drug copy, which is expected to hit the market at the end of 2017, will be marketed by STADA in geographical Europe and the CIS area, but not in Russia. Richter may grant one additional license to another partner in the region covered by the contract. In addition to a one digit million upfront payment, STADA will pay milestones totalling “a low double-digit million euro figure”.
Under the terms of the second contract, Richter will in-license a preclinical Trastuzumab biosimilar candidate from
STADA for a low single-digit million euro figure. STADA terminated development of the compound last year in the course of a restructuring process, and Richter said it had acquired the rights ”in order to accelerate its own ongoing development of a Trastuzumab biosimilar.” Richter says it expects clinical testing of the copycat drug to begin in two years. At that point in time, STADA will have the option to acquire a distribution license for the biosimilar, which will seek to mimic Roche’s €1.39bn blockbuster.
Experts expect the market for biosimilars to grow to US$10bn annually by 2015 as patents run out on a number of original biologicals – most of them therapeutic antibodies.