The European Commission has granted marketing authorization for Gedeon Richter Plc.’s biosimilar product, developed by Bio-Thera Solutions Inc. and will be marketed in Europe under the brand name Richter USYMRO, the Budapest-based pharmaceutical company announced on the Budapest Stock Exchange website on Wednesday.
In October 2024, Bio-Thera and Richter signed a licensing and commercialization agreement for USYMRO® (BAT2206). Under this partnership, Bio-Thera will handle the development and manufacturing of the product, while Richter has secured exclusive rights to market and sell the medicine in the EU, the UK, Switzerland, and select other countries, the company recalled.
USYMRO® is a biosimilar (medicine designed to work like already approved biological medication) to Stelara®, a treatment developed by Janssen.
It helps control the body’s immune system when it becomes overactive and causes inflammation.
This overactive immune response plays a role in conditions like psoriasis, psoriatic arthritis (PsA), and Crohn’s disease. USYMRO® works by blocking certain proteins (IL-12 and IL-23) that are involved in triggering inflammation. By targeting these proteins, USYMRO® helps reduce inflammation and manage the symptoms of these chronic conditions.
“We are pleased that Richter will further strengthen patient access to biosimilars in Europe through bringing USYMRO® to market. As a result of Bio-Thera’s success in gaining EC approval, Richter is expanding its biosimilar portfolio subsequent to the recent EC approvals of its in-house developed denosumab biosimilars,” the statement quoted Dr. Erik Bogsch, Head of the Biotechnology Business Unit of Richter, as saying.
Fact
Gedeon Richter Plc. headquartered in Budapest, Hungary, is a major pharmaceutical company in Central and Eastern Europe, with an expanding direct presence in Western Europe, China, Latin America, and Australia. The product portfolio of Richter covers many important therapeutic areas, including Women’s Healthcare, Central Nervous System (CNS), and Cardiovascular areas. Having the largest R&D unit in Central and Eastern Europe, Richter’s original research activity focuses on CNS disorders.
Via bet.hu, Featured image: Hungary Today
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