By Fineline Cube China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Biogen’s Tecfidera (dimethyl fumarate). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc.
Tecfidera: Drug Profile and Market Context
Tecfidera is used to treat multiple sclerosis (MS) and is the world’s third oral MS drug, following Novartis’s Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide). First approved in the US in 2013, Tecfidera obtained market approval in China with priority review status as a clinically urgent overseas new drug in April 2021 and was officially launched in the country in August. Other companies with generic approvals for Tecfidera in the US include Viatris, Reddy, and Cipla.
Future Outlook
With the FDA’s ANDA approval, Zhejiang Huahai is poised to enter the US market with its generic version of Tecfidera, further expanding its presence in the global pharmaceutical market and providing additional treatment options for patients with multiple sclerosis.-Fineline Info & Tech