The Canadian province of
British Columbia mandated
on May 27 that patients receiving public coverage who are using reference insulin
glargine, infliximab, and etanercept therapies must be switched to biosimilars in
the next 6 months. This has caused a predictable flaring of tempers, and
generated some opposition on my Twitter feed.
The article in the (Vancouver)
Globe and Mail announcing the
decision quoted the province’s health minister: “Biologic drugs continue to be
a growing pressure for public drug plans. If we continue to spend more and more
of our finite health dollars on biologics, it restricts our ability to provide
coverage for existing drugs … not to mention hindering our ability to list
any new drugs.” According to the article, British Columbia will save
nearly $100 million through 2022 as a result of the policy. This policy does
not affect those individuals who receive their drugs through private insurance
or employer-sponsored plans (which can act independently of the government).
Like in the US, Janssen’s Remicade®
still accounts for 92% of the infliximab utilization in Canada.
On the morning after the
decision was announced, opinion on Twitter was divided. One side acknowledged
the limited dollars available in the Canadian system. The other side wondering
whether this economic decision will result in deleterious outcomes. Here, I breakdown
some of the more notable negative responses:
“Specialists prefer the biologic to the biosimilar”
Any physician treating a patient with stable chronic disease would not want to change the drug regimen without good reason. However, the point of the tweet may have been that specialists actually believe the biosimilar to be inferior. In dozens of interviews with specialists, I’ve not found this to be the case. They accept the biosimilar to be safe and effective, as determined by the Food and Drug Administration (FDA), and that the biosimilar should not provide a greater risk to a treatment-naïve patient compared with the originator product. A new French study found that patients with ulcerative colitis taking Inflectra® actually had fewer serious side effects than those taking Remicade. Does this mean the biosimilar is a better medication? No one would claim this is the case. However, it is certainly no less safe.
“For teens hoping to live for decades, are 2-month to 1-year studies adequate?”
It is true that regulatory groups like the FDA do not require biosimilar agents to be subjected to long-term safety evaluations. The FDA has emphasized that it values the physiochemical and pharmacokinetic comparability to be far more important in biosimilar evaluations. In fact, the argument has been made that phase 3 trials are of very limited use in biosimilar testing.
That said, there are at least 2 areas where longer-term evidence does exist and can be generated: (1) the actual experience in Europe, where biosimilar infliximab has been available for use since 2014, (2) and the ongoing efforts of organizations dedicated to studying and monitoring postmarketing use and outcomes. For the former, see the previously cited French study, involving nearly 5,000 patients with ulcerative colitis. For the latter, consider the Biologics and Biosimilars Collective Intelligence Consortium in the US.
“Biosimilars, well, they’re synthetic, not the same at
Without regard to how the
writer defines “synthetic,” biosimilars are engineered proteins, just as reference
biologic are engineered and produced using live cell lines. Of course, no one
is arguing that biosimilars are exact copies of biologics. Even manufacturers
of interchangeable biosimilars would never infer this.
It has been pointed out
repeatedly that the originator drugs introduced years ago are, by our
definitions today, biosimilars of themselves, because of manufacturing changes,
production modifications, etc. Therefore, making the statement that biosimilars
“are not the same at all” is not really true, particularly if we view the
similarities in molecular structure, pharmacodynamics and pharmacokinetics, and