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Biosimilars approved in South Korea

Last update: 22 June 2018

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.

WuXi Biologics expands its biologicals manufacturing facilities

China-based WuXi Biologics, headquartered in Wuxi city of Jiangsu Province, is expanding its biologicals manufacturing capacity with new facilities planned in Ireland, China, Singapore and the US.

Biosimilars approved in Canada

Last update: 18 May 2018

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 the US

Last update: 18 May 2018

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).

Biosimilars highlights for 2017

There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimilars in 2017 [1]. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab‑qbtx), and Ogivri (trastuzumab-dkst), along with the approval of follow-on insulin lispro biological Admelog, by the US Food and Drug Administration (FDA).

AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar

Biosimilars maker Samsung Bioepis announced on 5 April 2018 that it had reached a ‘global resolution’ with pharma giant AbbVie ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

Biosimilars of cetuximab

Last Update: 13 April 2018

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer.

Biosimilars of insulin glargine

Last update: 16 March 2018

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

US drug contracting system is ‘rigged’ against biosimilars

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has said that the drug contracting system in the US is ‘rigged’ against biosimilars. His remarks came during a speech he made on 7 March 2018 at the America’s Health Insurance Plans National Health Policy Conference in Washington DC.

Cadila and Kalbe advancing biosimilar ambitions

Indian generics maker Cadila Healthcare (Cadila) and Indonesia-based Kalbe Farma (Kalbe) are both making advances into the biosimilars field.

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