Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application ...

Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required ...

Companies seeking to commercialize orphan drug biosimilars are likely to face challenges associated with limited potential market size, uncertainty regarding expanding patient access and loyalty to ...

Biopharmaceuticals include a complex active pharmaceutical ingredient (API). This is manufactured using living systems such as microbial and mammalian cells which makes manufacture a complicated ...

China’s National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) published draft measures entitled ‘Implementing measures for drug patent dispute ...