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Glossary of key terms

Last update: 12 January 2015

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Biosimilars approved in Japan

Last update: 5 December 2014

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

Subsequent entry biologics approved in Canada

Last update: 5 December 2014 

In Canada, the regulatory body for the approval of medicines is the Therapeutic Products Directorate of Health Canada.

EuropaBio calls for distinguishable names for biosimilars despite potential of big savings

On 6 November 2014, the European Association for Bioindustries (EuropaBio) published a new guide and a new position paper on biosimilars in Europe. EuropaBio expects these two documents to contribute to the policy debate on key issues regarding biosimilars among European and national regulators, policymakers, physicians, other healthcare providers, and patients.

More discussion over WHO biological qualifier

The World Health Organization recently held its 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals including biosimilars was once again discussed.

Biosimilars approved in South Korea

Last update: 21 November 2014

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 Europe

Last update: 14 November 2014 

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 of etanercept

Last update: 7 November 2014

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Biosimilars of pegfilgrastim

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils) [1]. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Biosimilars of darbepoetin alfa

Last update: 31 October 2014

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.