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EMA accepts application for ranibizumab biosimilar from Samsung Bioepis Biosimilars/News | Posted 23/10/2020

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...

Biosimilar assessments: do we need efficacy trials? Biosimilars/Research | Posted 23/10/2020

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 require...

Commercialization challenges for biosimilar orphan drugs Reports | Posted 23/10/2020

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 and biosimilars: manufacturing challenges Biosimilars/Research | Posted 23/10/2020

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 pr...

China’s draft measures for patent linkage system Policies & Legislation | Posted 23/10/2020

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

Reforms to health policy needed in Europe Generics/General | Posted 23/10/2020

The President of Medicines for Europe has made four key recommendations for European Union (EU) pharmaceutical policy,  while the Irish Pharmacy Union (IPU) says reforms to the health service...

Aurobindo and Huons refocus their biologicals/biosimilars portfolios Pharma News | Posted 23/10/2020

India-based generics maker Aurobindo Pharma (Aurobindo) has announced a renewed product focus and plans for the biosimilars of its subsidiary company. In addition, Korea-based Huons will collaborat...

Medicare Part D favours generics over brand-name drugs Generics/Research | Posted 23/10/2020

A recent assessment of Medicare Part D [1] finds that insurance plans favour generic drugs over innovator products. Fewer than 1% of plans covered only the brand-name version of a drug in 2019.