The research was conducted by the Institute of Experimental Medicine and led by Prof. E. Sylvester Vizi.Continue reading
The U.S. Food and Drug Administration (FDA) has accepted the application submitted by Gedeon Richter and Hikma for the approval of denosumab biosimilars (affordable versions of osteoporosis drugs, mimicking its safety and efficacy), Richter announced on the Budapest Stock Exchange’s website on Thursday.
The announcement highlighted that Hikma, a UK-based global company, entered into an exclusive sales and licensing agreement with Richter in December 2021. Under the terms of the agreement, Richter is responsible for developing the biosimilars and supplying the finished products for the U.S. market. Hikma, in turn, is responsible for handling the FDA registration process and holds exclusive rights to market the products in the U.S. once approved.
Erik Bogsch, head of Richter’s biotechnology division, described the FDA filing as an important milestone that strengthens the collaboration with Hikma.
Hikma’s significant presence in the U.S. market enables us to expand the reach of Richter’s biosimilar programs and bring these treatments to more patients worldwide,” Mr. Bogsch said.
As Hungary Today wrote earlier, this collaboration aligns with Richter’s broader strategy to strengthen its foothold in the U.S. pharmaceutical market, particularly through biosimilar development. The partnership with Hikma reflects Richter’s commitment to innovation and its pursuit of global partnerships to address key healthcare challenges effectively.
Via MTI; Featured Image: Hungary Today