Home / Biosimilars / General

General

Biosimilars applications under review by EMA – January 2018

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Biosimilars approved in South Korea

Last update: 12 January 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.

Biosimilars approved in Canada

Last update: 12 January 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.

Roche sues Pfizer over Herceptin biosimilar

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’s trastuzumab biosimilar.

Biosimilars approved in Japan

Last update: 5 January 2018

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

EC publishes biosimilar Q&A document for patients in 23 languages

On 29 November 2017 the European Commission (EC) published a patient-focused Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

Biosimilars of palivizumab

Palivizumab is a humanized monoclonal antibody. It targets the fusion protein of respiratory syncytial virus (RSV) inhibiting its entry into the cell and thereby preventing infection. Palivizumab is therefore used in the prevention of RSV infections.

UK launches campaign to promote research on biosimilars

A new campaign launched by the UK’s National Institute for Health Research (NIHR) aims to unlock the potential benefits of biosimilars in the National Health Service (NHS) through clinical trials.

Hospira to pay Amgen US$70 million for epoetin alfa patent infringement

US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a patent on Amgen’s anaemia blockbuster Epogen (epoetin alfa).

FDA launches educational campaign for biosimilars

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosimilars.