Biosimilars/General
Copy biologicals approved in China
Last update: 2 April 2021
In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).
Biosimilars approved in South Korea
Last update: 26 March 2021
In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.
IVM releases toolbox on how to switch patients to insulin biosimilars
The Dutch Instituut voor Verantwoord Medicijngebruik (Institute for Responsible Medicines Use, IVM) has released a toolbox for healthcare providers on how to switch patients to insulin biosimilars.
Biosimilar patent litigation trends in the US
According to authors from Law360 the trend in biosimilar patent litigation cases has been downward, with many cases being resolved and only five cases still pending as of 31 December 2020 [1].
Biosimilar approvals and launches in the US
An examination of biosimilar approvals by the US Food and Drug Administration (FDA) compared to launches was carried out by authors from Law360 [1].
Biosimilars approved in Australia
Last update: 26 February 2021
In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.
Biosimilar approvals and patent litigation in the US
Authors from Law360 have examined biosimilar approvals by the US Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and ensuing patent litigation actions. They also discuss why the lack of new approvals and litigation in 2020 does not suggest reduced interest in biosimilars but signals a new wave of biosimilars on the horizon [1].
Biosimilars of bevacizumab
Last update: 5 February 2021
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
Samsung biosimilars: denosumab clinical trials begin, while rituximab development is halted
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar, while development on a rituximab biosimilar through subsidiary company Archigen Biotech has been stopped.
Biosimilars of filgrastim
Last update: 22 January 2021
Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.
