Opinion: Patients On Biologics Need To Be Wary Of Substitutions
On a cool rainy day last month, more than 100 people rallied at the British Columbia legislature to fight for a drug that has improved the lives of those suffering with cystic fibrosis. The drug is expensive and those gathered at the legislature want it reimbursed by the provincial drug plan.
Shouting slogans and waving signs, their concerns are understandable: When it comes to medicine, all Canadians want access to the treatment that their physicians believe is best for them.
But while the issue over this medication — and others — is generating headlines, there is another health care issue that hasn’t hit the radar for most British Columbians. It involves a type of medicine called biologics, that are used to treat complex diseases such as cancer, diabetes, cardiovascular disease, osteoporosis, Crohn’s disease, rheumatoid arthritis and more.
Over the last decade, biologic medicines have improved health outcomes in some of the most difficult-to-treat chronic conditions, greatly improving the lives of millions of patients. There are exciting and inspirational advancements on the horizon, with many British Columbia companies at the forefront of this pioneering science.
But there is a growing concern involving biologics — and related drugs called biosimilars. Since it could affect you, or someone you love, allow me to explain.
The most common drugs we use — like the aspirin in our medicine chests — are the product of a chemical mixing process. Cheaper generic drugs — such as no-name brands — are made the same way, carbon copy medicines created using the same chemical recipe. These generic drugs are chemically identical to the brand name ones, and so some public and private drug plans may only cover the generic version.
But biologic medicines are different. Biologic drugs aren’t simple molecules, they are complex genetically-engineered proteins derived from living cells. These therapeutic proteins replace or augment human proteins and are programmed to perform a precise function within the body with enhanced precision to treat the target disease.
This precise and highly-complicated biotechnology is subject to all the same regulations and approvals as other medications.
Now, though, as patents on innovator biologic medicines start to expire, lower cost “biosimilars” are becoming more common in Canada — and they aren’t the same as the original. Biosimilars are similar, but not identical to the originator biologic and they aren’t interchangeable. In most cases, they aren’t made by the same company, haven’t used the same living cells and may not have employed the same manufacturing process.
For patients, this is an important distinction. If your doctor prescribes a biologic drug for a disease such as rheumatoid arthritis and you are switched to a biosimilar drug at the pharmacy for non-medical reasons, the substituted medicine may produce a different effect. In fact, Health Canada recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.
Confusing, yes. And it gets more complicated.
Currently, the two medications — the originator biologic drug and the biosimilar — have the same scientific name. This is despite the fact Health Canada has said biosimilars are not identical to their originator biologic counterpart and should not be deemed interchangeable.
Recently, the Alliance for Safe Biologic Medicines conducted a survey of Canadian doctors and found overwhelming support for creating distinguishable names for biologic and biosimilar drugs. Our survey also found that most doctors were not comfortable with a third party switching a patient’s medicine for non-medical reasons. Many worry the different medications may cause adverse effects in patients. I am hoping British Columbia, which is home to a vibrant biotechnology industry, will play a leadership role in working with Canadian physicians and stakeholders to develop guidelines on the responsible switching of originator biologics and biosimilars.
Biosimilars have a role to play in terms of offering patients and physicians lower cost alternatives and different therapeutic options. But for biosimilars to be introduced and used successfully, decision makers must rely on the input and opinions of those who prescribe them.
There is no doubt this is a complicated topic — and it still confuses many patients, doctors and pharmacists. But knowing what we are putting in our bodies is central to the care we receive.
Safety is paramount and the time for action is now. This issue is too important to make a mistake. Our health depends on it.
Michael Reilly is the Executive Director for the Alliance for Safe Biologic Medicines which is comprised of patients, physicians, pharmacists, health care groups and biotechnology companies.Original Source: http://vancouversun.com/opinion/op-ed/opinion-patients-on-biologics-need-to-be-wary-of-substitutions Original Date: Dec 25 2017 Original Author: Michael Reilly