Biosimilars/General
US doctors poised to prescribe biosimilars
A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.
Amgen sues Sandoz over etanercept biosimilar
Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.
Sandoz acquires EEA rights to infliximab biosimilar from Pfizer
Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.
FDA releases ‘Overview of Biosimilar Products’
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
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 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
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
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
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
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.
