Biologics are complex and highly sensitive medicines grown in labs from living cells such as blood, proteins and viruses. They differ hugely from conventional pharmaceuticals, like aspirin, which are chemically synthesized in an orderly, predictable process.
Biologics cover a wide variety of products, including vaccines, tissues, gene therapy and stem cells. Some biologics are well known. Botox is a biologic. So is the popular drug Humira, which is used to treat arthritis and other conditions.
While complex to produce and store, biologic medicines have dramatically improved the lives of patients, who often experience better health outcomes and fewer side effects than when they are treated with conventional pharmaceuticals. Some biologics are being used to treat conditions that had no treatments just a few years ago.
Biologics benefit not only patients and their caregivers, but also the healthcare system as a whole by reducing costs, reducing complications and improving the productivity of healthcare employees. These innovative medicines improve society’s standard of living and health, as well as help Canada meet its innovation goals.
The advent of genomics technology has revolutionized the field of biologics. We can now identify genetic causes or dispositions to disease and manufacture almost any type of DNA, proteins, antibodies or hormones.
Biosimilars are the pharmaceutical industry’s answer to producing an imitation biologic once the innovator’s patent has expired.
Biosimilars cannot be called “generic” versions of a biologic because they are too complex to be exact copies of the original. No two biologics can exactly match, which means they can never be precisely interchangeable the way conventional pharmaceutical generic drugs are.
Here is how Health Canada describes biosimilars: “A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale.” Biosimilars represent a legal or regulatory construct rather than a class of therapeutics.
Many healthcare companies are now producing biosimilars. As long as patient safety and an innovator’s intellectual property are protected, biosimilars can be used to provide choice for healthcare professionals and patients. They also allow for additional savings to both public and private payers, which can be reinvesting in new innovative therapies coming to the market.
Because biosimilars cannot be shown as interchangeable to the original biologic, they need to be tested and regulated just as rigorously as the original.