September 15, 2020
BIOSIMILARS: THE WORLD TURNED UPSIDE DOWN
Opening Remarks and Housekeeping Julie Arel, PMCQ President
- This was our 4th virtual event and we had a 59% attendance rate!
- We will continue to host our events virtually until early next year.
- Coming late 2020, we are introducing our new platform, which will provide an exceptional event experience. The new platform will help us manage in-person, hybrid, and virtual events with the goal to provide a seamless member engagement with us, and one another, before, during, and after events. Features include one-on-one messaging, live polling, session registration and better overall audience interaction for both virtual and live events.
- Thank you to Toc Toc Communications for doing the creative for this event and Sanofi for their sponsorship of the event.
- Our next meeting is a breakfast meeting on October 20th and will cover supply chain management — a hot topic, given current events!
Introduction of speaker Shannon Quinn, PMCQ Past-President
This meeting featured a moderated panel discussion with the following speakers:
- Bev Herczegh BScPhm, RPhm: Director at The Pangaea Group (moderator)
- Chander Sehgal, MD, MBA: Director, Market Access at Teva Canada Innovation
- Kevin O’Connor: Director, Federal and Private Healthcare at Janssen Inc.
Overview of biosimilars Bev Herczegh
- Biologic drugs are large, complex molecules derived through the metabolic activity of living organisms and tend to be significantly more variable and structurally complex than chemically synthesized drugs.
- A biosimilar biologic drug, or “biosimilar,” is a biologic drug that is highly similar to a biologic drug that was already authorized for sale (known as the “reference biologic drug”).
- Biosimilars are not the same as generic drugs.
- Generics: small molecules; chemically synthesized; can be duplicated exactly so that the active ingredient is chemically identical to the reference product; declaration of equivalence by Health Canada
- Biosimilars: large, complex molecules; manufactured in a living system; challenging to duplicate exactly; active ingredient is highly similar to reference product; no declaration of equivalence by Health Canada
- Structural and functional studies, as well as human clinical studies, demonstrating the similarity of the biosimilar to the reference biologic drug are required for Health Canada authorization; the evidence must show the biologic is:
- of suitable quality
- Based on structural similarity, there are no clinically meaningful differences in efficacy and safety between a biosimilar and the biologic it references. Large clinical studies comparing the efficacy and safety are not required for Health Canada approval.
- Health Canada can authorize the biosimilar for the same indications as the reference biologic drug; this concept is called “extrapolation” or “extension” of indications.
- Health Canada's authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug.
- The biologic may enter the market after the expiration of reference biologic patents and data protections.
- When a patient’s medicine is changed for a reason other than the health and safety of the patient, this is sometimes termed non-medical switching (NMS).
- This is usually for financial (payer) reasons to reduce costs for a government agency or employer.
On the impact of biosimilars on Canadian patients, clinicians, and the healthcare system:
- Patients and clinicians have more options available to them.
- Biosimilars provide savings for drug programs.
On the impact of non-medical switching:
- There is concern among some people that there haven’t been enough well-designed, long-term studies to assess the impact of non-medical switching, both on patient health and on the healthcare system’s finances. It is argued that there is a data gap, specifically in Canada, on whether biosimilars are actually able to help the healthcare system attain maximum savings, and that we shouldn’t just assume that non-medical switching leads to maximum savings. Currently, switching is commonly studied using non-inferiority endpoints. The margin to prove non-inferiority can be as high as 20%. Non-inferiority studies also tend to have small sample sizes. There is a need for well-designed studies that ask:
- What is the persistence rate of patients after they have been switched? Is it comparable to patients who have not been switched?
- What if there is treatment failure due to switching? What are the healthcare costs of those failures?
- The counterargument is that this is a ‘chicken-and-egg’ situation: we cannot understand the impact of non-medical switching if we are waiting to switch patients until we have enough data on switching. Furthermore, a demand for more data may give the impression that the clinical data currently available are unreliable. Doubt around the validity of the regulatory approval process has been one of the causes of the slow uptake of biosimilars in Canada.
- Health Canada has released its official statement: “Switching a reference product to a biosimilar should be made by a treating physician in consultation with the patient and taking into account available evidence and any policies of the relevant jurisdiction.”
- According to the statement, it is the jurisdiction’s prerogative to decide when switching is appropriate, and provinces like Alberta and British Columbia have already discussed implementing switching regulations — without the switch data.
On regulatory changes that enable and increase biosimilar adoption:
- CADTH used to review biosimilars using a customized process, until they announced last year that they no longer need to conduct these reviews. This decision was recommended and endorsed by the public drug plans.
- INESSS still reviews biosimilars.
- Additionally, some provinces still need some form of submission for biosimilars.
- Our speakers felt that these changes do not represent preferential treatment.
On patient support programs (PSPs):
- PSPs are quite involved in patient care and have become part of the new standard of care in North America.
- For biosimilar brands to succeed in Canada, they would need to have a PSP offering that is at least comparable to the innovator brand’s PSP.
- Starting a PSP is an expensive endeavour, and so biosimilar brands need to find a way to offer a PSP while maintaining the cost savings of the drug.
Questions from the audience
How is COVID-19 reshaping the biosimilar landscape?
- Some discussions have taken a back seat.
Are there references available to find a complete list of biosimilar products in Canada?
- There are two biosimilar industry associations that provide this information.
How broad does the clinical program need to be for biosimilars to get regulatory approval?
- You can look at the Summary Basis of Decision for any given product and see exactly how many studies were done for that product.
Is there a registry for biosimilars that can gather data on safety and efficacy post launch?
- It is not known if there are any registries, although the Government of British Columbia has collected some data on the number of patients that have switched to biosimilars.
Freelance Medical Writer