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General

Launch of partnership for biosimilars education and access

The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.

Biosimilars approved in Japan

Last update: 12 February 2016

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

Biosimilars of etanercept

Last update: 12 February 2016

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.

Biosimilar etanercept offered at 47% discount in Norway

Samsung Bioepsis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.

Biosimilars approved in Australia

Last update: 5 February 2016

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

‘Similar biologics’ approved and marketed in India

Last update: 5 February 2016

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

Biosimilars approved in Europe

Last update: 5 February 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.

Biosimilars applications under review by EMA – December 2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Similar biotherapeutic products approved and marketed in Latin America

Last update: 29 January 2016

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

What happened in biosimilars during 2015

The past year has once again been a busy one for the biosimilars industry. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.