FDA approves adalimumab biosimilar Hadlima

Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its ...

Korean firms to launch biosimilars in Japan despite trade tensions

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second ...

WHO essential medicines list: new lung cancer medicines rejected

The World Health Organization’s (WHO) list of ‘essential medicines’, received a biennial update on 9 July 2019. It added 28 drugs but left out several new treatments for lung cancer.

Biosimilars applications under review by EMA – July 2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval ...

Positive phase III results for bevacizumab copy biological IBI305

Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).