FDA Approves Richter’s Denosumab Biosimilars
The U.S. Food and Drug Administration (FDA) has accepted the application for the approval of denosumab biosimilars submitted by Gedeon Richter and Hikma, as announced by Richter on the Budapest Stock Exchange’s website. This marks a significant step in providing affordable versions of osteoporosis drugs that mimic the safety and efficacy of the original medication.
In December 2021, Hikma, a UK-based global company, entered into an exclusive sales and licensing agreement with Richter. Under this agreement, Richter is tasked with developing the biosimilars and supplying the finished products for the U.S. market, while Hikma handles the FDA registration process and gains exclusive rights to market the products in the U.S. upon approval.
Erik Bogsch, head of Richter’s biotechnology division, emphasized the importance of this FDA filing as a milestone that strengthens the collaboration with Hikma. He stated, “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.”
This partnership aligns with Richter’s strategy to establish a stronger presence in the U.S. pharmaceutical market, especially through biosimilar development. The collaboration with Hikma reflects Richter’s commitment to innovation and its efforts to address key healthcare challenges globally.
The research conducted in collaboration with Gedeon Richter recently unveiled key brain effects of antipsychotic drugs, showcasing the company’s dedication to advancing healthcare solutions. This partnership with Hikma and ongoing research endeavors highlight Richter’s position as a key player in the pharmaceutical industry.
Via MTI; Featured Image: Hungary Today
