The marketplace for medications is about to get a lot larger. The FDA recent approved the first biosimilar product called Zarxio (filgrastim-sndz) and expects to approve more of them soon.
Associate Director for Therapeutic Biologic Leah Christly, Ph.D., says we need to understand biological products before we can understand biosimilars.
Biologics are medications we make from living organisms. This can include animal, humans or microorganisms like bacteria or yeast. These are different from conventional medications which are usually made from chemicals or are chemically synthesized and have an easy to define structure.
Biologics aren’t made by following a chemical recipe as they come from living organism which vary in nature. These are more complex and not easy to characterize or define. They need a more complex process to manufacturer.
The FDA thoroughly and rigorously evaluates a biologic just like they would do for a regular drug before it gets approval. These biologics are the fasted growing segment of the market for prescription drugs.
A biosimilar is a type of biologic that is very similar to an already FDA approved biologic which is called the reference product. The biosimilar is not just a generic drug. The structure is very complex and it’s not easy to produce as a generic drug. The biosimilar isn’t a copy of another biologic, it’s just very similar to it.
Before any biosimilar is approved by the FDA. It’s verified by experts to make sure there are no clinical meaningful differences between the reference product and the biosimilar.
The biosimilar must also have the same dosage form and strength as well as route of administration as the reference product. The Current Good Manufacturing Practices must be used in the manufacturing of the biosimilar.
FDA approved biosimilars are effective and safe and patients can rely on them. A physician must approve the biosimilar just like they need to approve a biologic. In the marketplace for medications the biosimilar products will create greater competition. This will increase the number of treatment options for patients and lead to less expensive alternative therapies when compared to regular treatments. There are many biosimilars on the market now and consumers get an effective and safe treatment when they use the product at lower costs to them.