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Non-originator biologicals approved in Russia

Last update: 10 January 2020

In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav, Minzdrav).

Canadian gastroenterologists issue biosimilar position statement

The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the treatment of inflammatory bowel disease (IBD) [1].

WHO launches insulin prequalification programme

The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin in order to increase supply in low- and middle-income countries.

UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars

The largest insurer in the US, UnitedHealthcare, has announced it will preferentially cover Amgen’s biosimilar cancer treatments from 1 October 2019.

Biosimilars of ranibizumab

Last update: 6 December 2019

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1]. 

Biosimilars of etanercept

Last update: 6 December 2019

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 infliximab

Last update: 29 November 2019

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Biosimilars approved in Australia

Last update: 22 November 2019

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

Biosimilars of pegfilgrastim

Last update: 22 November 2019

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). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Similar biotherapeutic products approved and marketed in Latin America

Last update: 29 November 2019

Regulation of similar biotherapeutic products in Latin America varies widely among different countries. Although many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].