Biosimilars/General

FDA releases ‘Overview of Biosimilar Products’

Biosimilars/General | Posted 26/02/2016

As part of its ongoing mission to educate industry, the public and healthcare professionals about biosimilars, the US Food and Drug Administration (FDA) has released an online educational course for healthcare professionals.

Celltrion to use cloud-based technology for its biosimilars trials

Biosimilars/General | Posted 19/02/2016

On 20 January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).

Biologicals patent expiries

Biosimilars/General | Posted 13/11/2015

Biosimilars are now a reality. The European Medicines Agency (EMA) approved its first biosimilar back in 2006 [1] and, with the increasing price of new biologicals and continuing pressure on healthcare budgets, biosimilars are expected to make up an increasing share of the biologicals market.

Launch of partnership for biosimilars education and access

Biosimilars/General | Posted 12/02/2016

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.

Inflectra PBS listing expected to deliver savings in Australia

Biosimilars/General | Posted 08/01/2016

The infliximab biosimilar Inflectra was approved for listing in Australia’s Pharmaceutical Benefits Scheme (PBS) on 1 December 2015. This is a decision that ‘will deliver immediate savings’ to the Australian Government, according to the Generic and Biosimilar Medicines Association (GBMA), a group that represents generic and biosimilar medicine suppliers in Australia.

Outcry at new US biosimilars reimbursement policy

Biosimilars/General | Posted 04/12/2015

A newly announced US Centers for Medicare and Medicaid Services (CMS) rule that gathers together all biosimilars of a single reference product under just one code has been widely criticized by drugmakers. Drugmakers warn that the rule on Medicare physician payment would reduce incentives for developing biosimilars, reduce patient access and create safety issues due to the inability to differentiate between biosimilars and reference products.

Biosimilar naming in the US, the debate continues

Biosimilars/General | Posted 20/11/2015

The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.

Generics group established first voice for biosimilars in Canada

Biosimilars/General | Posted 27/04/2015

The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 2015 that it had set up a new CGPA Biosimilars Board, with Mr Michel Robidoux, President and General Manager of Sandoz Canada, as its inaugural Chair.

Australia’s DoH seeks feedback on biosimilars awareness project

Biosimilars/General | Posted 16/10/2015

Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do this the DoH has developed an implementation framework, for which it is seeking feedback.

Call for compulsory license for biosimilar trastuzumab emtansine

Biosimilars/General | Posted 23/10/2015

A pressure group, which includes both patients and doctors, has called for the UK Government to overturn patents on Roche’s breast cancer treatment Kadcyla (trastuzumab emtansine).