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General

Improving understanding of biotherapeutics and biosimilars

Additional information on biosimilars and biotherapeutics have been published in Europe.

Extension of indications and manufacturing approval for biologicals in the US

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

FDA guidance sought on false and misleading information on biosimilars

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.

Biosimilars approved in Australia

Last update: 31 August 2018

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

Biosimilars approved in the US

Last update: 31 August 2018

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).

European nurses launch biosimilar switching guide

The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from reference biologicals to biosimilars.

Biosimilars approved in Europe

Last update: 24 August 2018

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 approved in Japan

Last update: 24 August 2018

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

Biosimilars of infliximab

Last update: 20 July 2018

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 of rituximab

Last update: 20 July 2018

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.