STADA and Bio-Thera Solutions have received a positive recommendation from the EMA for their golimumab biosimilar Gotenfia, paving the way for its commercialization across Europe and enhancing patient access to essential treatments.

Information on the Target

STADA Arzneimittel AG is a global company based in Bad Vilbel, Germany, specializing in the development and commercialization of specialty pharmaceuticals, generics, and consumer healthcare products. The organization operates in over 100 countries, offering a diverse range of medical solutions designed to improve patient outcomes. One of its most recent developments is the biosimilar Gotenfia (golimumab), which is aimed at chronic inflammatory autoimmune diseases and holds significant market potential.

In collaboration with Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou, China, STADA is moving to commercialize the Gotenfia biosimilar in various European markets. The positive opinion from the European Medicines Agency (EMA) represents a critical step toward obtaining marketing authorization for this product, which is anticipated to enhance patient access to effective treatments.

Industry Overview in the Target’s Country

The biosimilars market in Europe is rapidly evolving, driven by increasing demand for affordable biological therapies that serve as alternatives to high-cost biologics. The European ma