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Merck launches biosimilars educational resource for patients

US pharma giant Merck (known as MSD outside the US and Canada) has launched an online resource intended to be used as an educational platform for patients, caregivers and the healthcare community.

Biosimilars approved in Europe

Last update: 21 October 2016

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.

Court rules in favour of Apotex in biosimilars dispute

Biosimilars specialist Apobiologix, which is part of the Apotex group, announced on 9 September 2016 that it had won its battle in the US against biologicals giant Amgen with respect to its filgrastim (Grastofil) and pegfilgrastim (Lapelga) biosimilars.

Biosimilars approved in Japan

Last update: 14 October 2016

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

Biosimilars approved in Australia

Last update: 7 October 2016

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

Subsequent entry biologics approved in Canada

Last update: 7 October 2016 

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 adalimumab

Last update: 30 September 2016

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumor 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 the US

Last update: 30 September 2016

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).

Biosimilar User Fee Act reauthorization

On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting support from industry associations.

Biosimilars of infliximab

Last update: 16 September 2016

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.

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