Biologics are very specific, highly effective medicines made in living cells. They improve health in many complex conditions, including Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, growth deficiencies, and more.
Some examples of biologics include hormones, blood products, cytokines, growth factors, vaccines, gene and cellular therapies, fusion proteins, insulin, interferon, and monoclonal antibody (mAb) products. Patients receive biologics by injection or infusion and cannot take them orally, since the process of digestion breaks down the biologic, making it ineffective.
Biosimilars – How are these Different?
Biosimilars are products that are similar to an already existing brand-name, original biologic (innovator or originator biologic) but, unlike a generic drug, are not identical. To understand why, we need to look at how biologics are different from other medicines.
Small Molecule: Most medicines, such as aspirin, are small molecule products, which means they have simple molecular structures. These simple structures make it easy to produce or copy. Once a patent expires, other companies can make copies of small molecule drugs by reproducing the exact same active ingredient (typically a chemical) as the original product. After Health Canada approval, they can then sell this as a generic version. The original product and the generic copies are considered bioequivalent because the active part of the medicines behave the same way in the body.
Biologics: By comparison, biologics are very large and have complex molecular structures. They are produced by living cells, from highly specialized ingredients using a complex biotechnology process. It is impossible to produce an exact copy without using the exact same ingredients, the same living cell lines, and identical manufacturing conditions.
As with other medicines, once a patent expires for a biologic, it is legal for other manufacturers to reproduce the drug. However, the innovator company doesn’t have to share its patented manufacturing processes (which may include the room temperature, the type of cells that produce the biologic, and the food the cells use to grow), and since there is always variability in a live biological system, it is impossible for a biosimilar to be an identical copy. Since biosimilars are not identical, they are not generic versions of the biologic they are copying.
With small molecule drugs, there are often many generic versions, and they all work the same. For example, whether you buy name brand acetylsalicylic acid (Aspirin) or one of the many generic versions, they perform the same in the body. However, with biologics, there could be many different biosimilars all referencing one innovator medicine, and each have a different manufacturing process resulting in a similar molecule to the innovator biologic, but not necessarily as similar to each other. With any biologic product, one batch of a biologic drug may not be exactly the same as the next, but they are required to be within a tight range.
Benefits of Biosimilars
The cost of pharmaceuticals, particularly biologics, is an important consideration as experts look at ways to make pharmaceutical care sustainable. Because they are complex and have revolutionized the treatment for many diseases, biologic medicines are costly and consume a large portion of public and private drug spending. In most cases, biosimilars are less costly than the innovator biologic, given that fewer clinical trials are required for biosimilars. Biosimilar manufacturers can extrapolate scientific evidence from one indication to another, which leads to fewer development costs. Biosimilar manufacturers focus on manufacturing processes that result in a similar product as well as studies demonstrating clinical similarity to the innovator biologic. These approaches are less expensive than the clinical trials required for initial drug approval for the innovator biologics.
Treatment options are very important for patients who have serious health conditions. With appropriate regulations in place around approval, advertising, and post-market monitoring, as well as private and public insurance coverage, products that demonstrate a safe and effective track record offer new treatment options for patients.
Biosimilars are safe and effective medicines that provide additional, lower-cost options for patients who are newly-prescribed biologics. However, prescribing medicines to treat chronic conditions should remain a decision between patients and their physicians, and should not occur for purely financial reasons.