Biosimilars/General

Biosimilars applications under review by EMA – August 2017

Biosimilars/General | Posted 22/09/2017

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.

WHO launches consultation on prequalification of biosimilars

Biosimilars/General | Posted 15/09/2017

The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifying biosimilars in October 2017. The step is intended to make ‘some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.

Australia’s TGA consults on naming of biologicals

Biosimilars/General | Posted 01/09/2017

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 28 July 2017 that it was opening a consultation on how to name biologicals.

Setback in Biocon/Mylan’s biosimilar programme after GMP inspection

Biosimilars/General | Posted 11/08/2017

Biocon/Mylan’s biosimilar programme has hit a stumbling block after failing an inspection by the French inspecting authority (L’Agence nationale de sécurité du médicament et des produits de santé: ANSM).

UK investigation suggests Merck broke competition law

Biosimilars/General | Posted 23/06/2017

A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an anticompetitive discount scheme for anti-inflammatory drug Remicade (infliximab).

Recommendations to enhance transparency of biosimilar labels

Biosimilars/General | Posted 16/06/2017

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label’.

Biosimilars applications under review by EMA – April 2017

Biosimilars/General | Posted 19/05/2017

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.

WHO to launch prequalification programme for biosimilars

Biosimilars/General | Posted 12/05/2017

The World Health Organization (WHO) announced on 4 May 2017 that it would launch a pilot project for prequalifying biosimilars. This move says the organization, is a ‘step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.

Fujifilm ramps up biosimilars production as UK court allows Humira biosimilar

Biosimilars/General | Posted 28/04/2017

A UK court has ruled in the favour of Japan-based Fujifilm Kyowa Kirin Biologics’ Humira biosimilar. The Fujifilm corporation has also announced a multi-million-dollar investment in its biologicals production facilities in the US.

Increasing access to biosimilars and generics in Europe

Biosimilars/General | Posted 14/04/2017

On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.