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Alteogen gains patent on SC trastuzumab biosimilar Pharma News | Posted 10/05/2019

South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).

FDA approves etanercept biosimilar Eticovo Biosimilars/News | Posted 03/05/2019

Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanerc...

ASCO/ASH update ESA recommendations Biosimilars/Research | Posted 03/05/2019

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have updated their recommendations on the management of cancer-associated anaemia with erythropoiesis-s...

WHO says more communication and education needed to increase access to biosimilars Reports | Posted 03/05/2019

The World Health Organization (WHO) has emphasized the importance of communication, trust and education in order to increase patient access to biosimilars in high-income countries. The issues were...

Mixed beliefs about generics among patients in a Malaysian hospital Generics/Research | Posted 03/05/2019

The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for all citizens. In 2017, total healthcare expenditure in the country was ap...

Biosimilar comparability assessment Biosimilars/Research | Posted 03/05/2019

In a recent review, Ishii-Watabe and Kuwabara summarize the principles of biosimilar development and outline key considerations for studies comparing a biosimilar with its reference product [1].

Health Canada issues draft guidance on generics labelling and equivalence Guidelines | Posted 03/05/2019

Canada’s federal department responsible for health, Health Canada, has issued two new draft guidance documents for public consultation as part of the agency’s effort to clarify the eligibility crit...

Australia’s TGA considering whether to publish drugs under evaluation Policies & Legislation | Posted 03/05/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) is consulting on whether it should publish that a prescription medicine is under evaluation.