18 February 2015.
The Generic Medicines Industry Association (GMiA) welcomes the announcement from member company, Hospira that its biosimilar infliximab (InflectraTM) is now available in more major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden.
Inflectra is the first biosimilar monoclonal antibody to be approved in Europe. It provides a more affordable treatment option for patients suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease.
“Now, patients in these major European countries can benefit from the patent expiry of reference product Remicade® (infliximab) and, as a result of competition, the savings expected to be generated from biosimilars can provide an opportunity to improve patient access to life-changing medications.” said GMiA CEO Belinda Wood
“And this is a great sign for Australian patients. As the Therapeutic Goods Administration looks to Europe for guidance on biosimilar regulation, we look forward to Australian patients soon being able to access biosimilar infliximab.”
“Significant market entry barriers currently exist in the regulation and reimbursement, prescribing and dispensing of biosimilars. These market entry barriers need urgent attention and GMiA recommends the implementation of a clear and predictable market access pathway, with uptake drivers, for biosimilars.”
Biosimilars provide a unique opportunity to help manage the growing costs of biological medicines on the Pharmaceutical Benefits Scheme.
“Savings can only be realised if more affordable biosimilars are prescribed and dispensed. For Australia to realise all the benefits of biosimilars, it is important that market uptake drivers are implemented to encourage the use of biosimilars and the GMiA looks forward to working with Government on these.” said Ms. Wood. – ENDS-