A Broken System: The Ongoing Saga of Originator Biologics and Biosimilars
July 16, 2018
Biologic drugs offer hope and health to a large number of Canadians living with serious disorders. When these medicines first entered the market, prescribers and patients quickly recognized them as revolutionary and the industry followed suit.
Today, biologics represent over 20% of the Canadian drug market1 and the category shows no signs of slowing down. Great news for patients? It can be, as long as policies move forward to contain costs and balance the market. With the health system careening toward unsustainability, this needs to happen.
When “biosimilars” – drugs designed to deliver the same clinical benefits as existing biologics, but at a lower cost – came along, they offered a welcome path toward the more balanced, sustainable market we would all like to see. But that’s not what is actually happening. The traditional life cycle of a drug – patent protection, patent expiry, followed by high uptake of lowcost generics – has not played out in the biologic arena. It’s a new game with new rules and stakeholders have largely clung to the status quo, with the result that patients remain on the higher-priced and better-known originator molecules.
Consider infliximab, the highest-earning biologic in Canada with annual sales of about $1.1 billion.2 Six years after Remicade’s loss of patent, two biosimilar versions of infliximab have stepped in – but Remicade continues to dominate with a market share of over 95%.2 The post-patent life of another popular biologic, etanercept, has followed a similar arc. Clearly, today’s market is not set up to give biosimilars their rightful place alongside originators. Why the resistance to change? For one thing, while biosimilars have no clinically meaningful differences from their corresponding originators,3 they do not have the label of interchangeability. This leaves the power to switch in prescribers’ hands, and prescribers have largely stuck with what they know. And why not? Patients are stable on their current biologic therapies, and most payers are still paying for the originator drugs and have not mandated a switch.
If we cannot save money on existing products after their patent expiry, we will not be able to pay for the new, disruptive therapies that move patient care forward.
Let’s start by learning from isolated success stories such as filgrastim, a biologic used to correct some acute effects of cancer treatment. Two years post-launch, the filgrastim biosimilar has captured as much as 50% of the market share, by some estimates – simply because payers enacted listing changes favouring the biosimilar. With the right push, biologics for chronic conditions could follow a similar trajectory.
We can also take our cue from countries such as Norway, where biosimilars have seen price drops as great as 72%.4
The Canadian market has a place – and a need – for both originators and biosimilars. We must simply establish the right balance between the two. With the health care system under mounting pressures, the way forward is clear: follow the evidence and responsibly contain costs. Patients across the country are counting on it.
Despite the underwhelming performance of biosimilar products to-date, new biosimilars continue to enter the market. Clearly, manufacturers believe these products can earn their rightful place alongside originator molecules. And they can – if supported by forward-thinking policies and practices.
References
1. Adapted from CADTH Biosimilars Environmental Scan: Biosimilars – Regulatory, Health Technology Assessment, Reimbursement Trends, and Market Outlook, January 2018, and IMS 2016 sales figures.
2. Adapted from IQVIA Canadian Pharmaceutical Industry Review 2017.
3. Government of Canada. Fact sheet: biosimilars. https://bit.ly/2L61bup
4. Gabi Online. Huge discount on biosimilar infliximab in Norway. https://bit.ly/2KXqema