Biosimilars/General
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United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.
Generics group established first voice for biosimilars in Canada
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
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
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).
European paediatricians advocate biosimilar trials in children with IBD
Paediatricians from Europe are concerned about the extrapolation of the limited amount of available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) [1].
Dutch medicines agency aims to clarify biosimilars confusion
The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.
