Biosimilars/General

European nurses launch biosimilar switching guide

Biosimilars/General | Posted 24/08/2018

The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from reference biologicals to biosimilars.

US pharmacies sue J&J for stifling infliximab biosimilars

Biosimilars/General | Posted 13/07/2018

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).

Biosimilars applications under review by EMA – June 2018

Biosimilars/General | Posted 06/07/2018

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.

Biosimilar infliximab blocked in Australia

Biosimilars/General | Posted 29/06/2018

Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.

AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar

Biosimilars/General | Posted 04/05/2018

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).

Spanish associations sign biosimilars collaboration

Biosimilars/General | Posted 22/06/2018

The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agreement that includes the creation of a joint working group to share up-to-date information on biosimilars.

WuXi Biologics expands its biologicals manufacturing facilities

Biosimilars/General | Posted 15/06/2018

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 highlights for 2017

Biosimilars/General | Posted 11/05/2018

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).

Biosimilars of cetuximab

Biosimilars/General | Posted 14/08/2014

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.

US drug contracting system is ‘rigged’ against biosimilars

Biosimilars/General | Posted 16/03/2018

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.