Biosimilars/General

Biosimilars of ustekinumab

Biosimilars/General | Posted 09/04/2021

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

Biosimilars of aflibercept

Biosimilars/General | Posted 02/04/2021

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.

Copy biologicals approved in China

Biosimilars/General | Posted 15/03/2019

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 Canada

Biosimilars/General | Posted 31/01/2014

Last update: 19 February 2021

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 12 February 2021

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

Biosimilars approved in South Korea

Biosimilars/General | Posted 14/03/2014

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

Biosimilars/General | Posted 19/03/2021

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.

Biosimilars approved in Japan

Biosimilars/General | Posted 07/03/2014

Last update: 12 March 2021

In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).

Biosimilar patent litigation trends in the US

Biosimilars/General | Posted 05/03/2021

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].

Biosimilars approved in the US

Biosimilars/General | Posted 14/08/2015

Last update: 5 March 2021

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).