Biosimilar medicines are a part of today’s therapeutic armamentarium – a “must-have weaponry” and a “catalyst for equal access” for physicians [1]. They have a track record of delivered healthcare benefits over the years.
Armed with over 10 years of positive clinical experience, physicians and patients are now focusing conversations on the long-term future of biosimilars, exploring how best to introduce biosimilar medicines in medical practice and ensure feedback in the post-authorisation phase.
So, what are the important questions remaining to be addressed?
US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.
In the EU, where biosimilars have been present for over a decade, the definitions of switching, interchangeability and substitution are as follows…
The harmonisation of different regulatory environments in the EU member states will help generic drugs enter the market, resulting in reduced prices for medicine and better patient access, Jacek Glinka told EURACTIV.com in an interview.
Jacek Glinka is the president of the Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical industries.
He spoke with EURACTIV.com’s Sarantis Michalopoulos and Hannah Black.
Biologic medicines have revolutionised the management of many serious diseases over the last three decades. However, the potential of biologic medicines has not been fully realised, as many patients who could benefit from these state-of-the-art treatments do not have real access to them.
Biologic medicines have revolutionised the management of many serious diseases over the last three decades. Unfortunately, the potential of biologic medicines has not been fully realised, as many who would benefit from these state-of-the-art treatments cannot effectively access them. A key driver of this limited availability is the increasing struggle to finance new medicines within healthcare systems. I have talked with so many passionate people – patients, physicians, experts – who face this reality every day. We have to work together to overcome this hurdle, and ensure patients have access to the treatments they need.
The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.
But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.
The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet.