The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris
Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026
The launch of HULIO in the United States is an important milestone for Biocon Biologics
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Despite nearly 20 years of availability, biosimilars show worldwide adoption rate of only 14% in initiative-tracked countries, while reference medicines still represent 86% of biologic
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
The successful outcome of this study represents an important milestone in Dr. Reddy's commitment to make highquality biosimilar products more accessible and affordable
Milan is also an important hub for the distribution of pharmaceuticals to the rest of Europe
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