Many drugs developed are called biological products (known as biologics, also known as the reference product) because they are produced through biotechnology and use living systems, such as a microorganism or a plant cell. Monoclonal antibodies and vaccines are some examples of biological products. Because the makeup of biologics are very complex, it is hard to create imitations of the drug. Some drug development is simple, like following a recipe with standard ingredients. For instance, generic drugs are chemical copies; they use the same active ingredients as brand-name medicines and work the same way. Biosimilars are more challenging because they are made up of living cells, which are very sensitive to their environments and cannot be recreated by a chemical formula. Manufacturers have to create their own, unique process to create an identical outcome to an existing treatment.
- Are imitations of biologics (the FDA-approved reference product)
- Are highly similar to their reference products- this means that the product is analyzed using technology that compares the characteristics of the reference product and the biosimilar.
- Have no meaningful differences – this means that the manufacturer of the biosimilar has shown that there are no differences between the reference product and the biosimilar in terms of safety, purity and potency (safety and effectiveness). This is shown by putting the biosimilar through human clinical trials.
Generic vs. Biosimilars
Both are versions of FDA-approved brand name drugs
The active ingredients are same as the reference product; an exact copy of the reference product.
The active ingredients are highly similar to reference product, without any clinically meaningful differences; not an exact copy of the reference product.
Manufacturer must show generics are bioequivalent to the brand name drug.
Manufacturer must show no clinically meaningful differences between the biosimilar and reference product in terms of safety and effectiveness.
FDA-approved based on matching chemical structure.
FDA-approved after clinical trials prove that the outcome of the drug matches that of the biologic it is imitating even though it looks structurally different.
There are currently many biosimilars in the process of being developed and some have been approved by the FDA. Visit the Drug Listings page for more information.
When biosimilars do become available as treatment options for blood cancer, treatment decisions may be dictated by your insurance company’s formulary. It is important to discuss all concerns about treatment options with your hematologist-oncologist and the pharmacist at your specialty pharmacy.
For more information about biosimilars, speak with an Information Specialist.