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Oncology pharmacists issue position statement on biosimilars

On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the use of biosimilars in cancer treatment and supportive care.

Biosimilars approved in Japan

Last update: 15 November 2019

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

Biosimilars of adalimumab

Last update: 15 November 2019

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Biosimilars approved in Canada

Last update: 8 November 2019

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.

Biosimilars of bevacizumab

Last update: 8 November 2019

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Biosimilars approved in the US

Last update: 4 November 2019

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Biosimilars of epoetin alfa

Last update: 4 November 2019

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Biosimilars approved in Europe

Last update: 25 October 2019

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.

Celltrion and Juno make biosimilars deal in Australia and Herzuma launches in Iraq

South Korean biotechnology company Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) to market the trastuzumab biosimilar Herzuma and rituximab biosimilar Truxima in Australia. The company also launched Herzuma in Iraq.

FDA releases new patient guidance on biosimilars

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

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