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General

Biosimilars approved in Europe

Last update: 14 December 2018

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 Australia

Last update: 14 December 2018

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Biosimilars approved in Japan

Last update: 14 December 2018

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

Biosimilars approved in Canada

Last update: 14 December 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.

Boehringer Ingelheim and Sandoz abandon biosimilars

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Merck gains US infliximab contract but drops insulin glargine biosimilar

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

Originator biologicals and biosimilars under attack in UK and Japan

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Biosimilars of trastuzumab

Last update: 6 July 2018

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Comments on FDA’s public meeting on biosimilars

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.

Biocon’s biosimilars plant gains clearance from FDA

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.