biosimilars aren’t coming, they’re here.
in 2010 health canada published the HC Guidance document: information and submission requirements for biosimilar biologic drugs. in April 2018, health canada approved the first oncology biosimilar. here we are today, may 2019- and well not much has changed.
i remember attending my first meeting on biosimilars, about three years ago. i remember being confused about what biosimilars were; what it would mean for cancer patients who were doing well on their current medication; what it would mean for policy and decision makers looking to save a quick buck, and if the savings they estimated were real; and back then how these drugs were being developed and approved.
and here we are three years later, and so much more information has been made available, so much more data, more education, more meetings. and in canada, we are still waiting to know how biosimilars will be implemented into the oncology landscape.
a biosimilar is a biologic medicine that is developed to be highly similar to an existing biologic medicine. biosimilars can be marketed once all regulatory exclusivity and intellectual property right periods for the reference product have expired.
as the global pharmaceutical spend continues to increase on biologics, biosimilars can provide an opportunity for healthcare systems to deliver significantly improved access to modern therapies for canadian patients in both the chronic and acute disease space, and specifically in cancer where rising drug prices have become an increasing challenge for payors.
but what message are we trying to put out there?
biosimilars are predicted to cost about 30% less than biologics. they are also predicted to decrease healthcare spending on drugs significantly. they have the ability to deliver sustainability to healthcare systems to allow for faster expanded access to new and novel innovative therapies. but will the promise of sustainability be realized if the message surrounding biosimilars is about cost savings rather than improving access and bringing better value to patients and healthcare systems?