Biosimilars/General

US senators call for guidance on biosimilars

Biosimilars/General | Posted 05/09/2014

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

WHO investigates use of a biological qualifier for biosimilars

Biosimilars/General | Posted 11/04/2014

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.

Physicians believe biosimilars should have different names

Biosimilars/General | Posted 29/08/2014

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

WHO proposal offers clarity for biosimilar nomenclature

Biosimilars/General | Posted 14/08/2014

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.

32 organizations agree biosimilars should have same names

Biosimilars/General | Posted 04/07/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals and biosimilars to have the same International Nonproprietary Name (INN).

ECCO position statement on biosimilars

Biosimilars/General | Posted 27/06/2014

The European Crohn’s and Colitis Organisation (ECCO) is a non-profit association with the aim of improving the care of patients with inflammatory bowel disease (IBD) in Europe. The association currently includes 2,519 individual experts, 33 country members and 17 corporate members.

Top 8 blockbuster biologicals 2013

Biosimilars/General | Posted 06/06/2014

The top three best-selling drugs during 2013 were biologicals. All three best-sellers are indicated for the treatment of arthritis, and include Abbott’s Humira (adalimumab), Merck’s Remicade (infliximab) and Roche’s Rituxan/MabThera (rituximab).

Biosimilars applications under review by EMA – April 2014

Biosimilars/General | Posted 16/05/2014

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 New Zealand

Biosimilars/General | Posted 02/05/2014

Last update: 2 May 2014

In New Zealand, the regulatory body for the approval of medicines, including biosimilars, is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

Biosimilars knowledge gap needs addressing

Biosimilars/General | Posted 18/04/2014

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars.