I’ve heard about biologic drugs but apparently the drug I’ve been prescribed is a “subsequent-entry biologic” drug. What does that mean? Is it the same thing as a generic drug?

May 20, 2016

That’s a great question as we’re going to be seeing a lot more biologic drugs and subsequent-entry biologic drugs (SEBs), sometimes called biosimilars, becoming available to Canadians.

Last month we explained what biologic drugs are, so let’s review: Biologic drugs are produced using living cells or microorganisms, such as bacteria, under very controlled conditions. These types of drugs are complicated and expensive to manufacture when compared to traditional chemical drugs. Manufacturing a traditional drug is much more straightforward as it’s somewhat like following a recipe – if you follow the instructions, you know exactly what you’re going to get.

As you might have guessed from the name, an SEB is a type of biologic drug, but it is a copy of a specific original “innovator” biologic drug. While that sounds like it’s a generic biologic drug, that’s not the word we use to describe the manufacturing process in this case. A drug manufacturer can control the process when making biologic drugs, but, because the drug is produced from a living organism, the manufacturer can’t completely control the results. This is what makes biologic drugs so complex to make and difficult to reproduce. So, unlike generic drugs which are chemically identical to the original brand-name drug, an SEB is similar but not identical to the innovator biologic.

Drug regulators like Health Canada understand these unique aspects of biologic drugs and have a separate process for evaluating and approving SEBs to enter the market. Health Canada analyzes the structure and pharmacology of the SEB to ensure that it is highly similar to the innovator drug and that any difference in structure does not impact the effectiveness and safety of the SEB. They actually require clinical data to demonstrate the effectiveness and safety of the drug.

Currently in Canada, these three SEBs have been approved by Health Canada.SEBs are similar to generic drugs in one important way: they can be vastly less expensive than the innovator drug. This brings greater competition to the market, driving prices down and allowing for greater patient access to biologic treatment.

The number of biologic drugs is expected to continue to grow – there are currently many biologics in the drug manufacturers’ pipelines for a variety of diseases and conditions. And as more biologics are developed, more SEBs will follow. For patients, SEBs offer safety, effectiveness, and a treatment experience comparable to an innovator biologic, but with significant cost savings to patients and the health care system.