The term biological or biosimilar medication is probably a new one for the average American. But these new medications are now becoming available in the US for the first time.
Medications come from many sources. Some are derived from plants, such as the heart failure drug digitalis (brand name Lanoxin), which is made from foxglove. Others like synthetic aspirin are made from chemicals and are designed to mimic plant medications. The active ingredient in aspirin is extracted from willow bark.
Most conventional medications are made from chemical combinations, which can be patented. When the patent runs out, however, other manufacturers can produce them and the cost usually drops significantly. These lower-cost medications are known as generics.
Both biosimilar and biological medications are like generics in terms of cost, but are not exactly the same as the medications they replace.
All About Biosimilar and Biological Products
Biological products are made from living organisms, including humans, animals, bacteria and yeast. They can be manufactured using biotechnology, derived from natural sources or produced synthetically.
Some vaccines, for instance, are created from viruses. Botox, used in cosmetic procedures to reduce wrinkles, comes from a bacteria. Insulin, the hormone that regulates blood sugar in the body, is often used in the treatment of diabetes.
Others include human growth hormone, some cancer treatments and medications for inflammatory diseases like arthritis.
Biosimilars are not exactly the same as biological products, but are considered interchangeable with the original biological product, known as the reference product. A biosimilar product should work in the same way and produce the same results as the reference product.
Generics Vs. Biosimilars
Generic medications are the same in chemical composition and effect as the more expensive, conventional medications they replace.
Unlike conventional medications, which are made from chemical substances, biological and biosimilar products are made from living organisms.
Biosimilars and the FDA
When a manufacturer develops a biosimilar product, it must submit an application to the US Food and Drug Administration (FDA). The application includes relevant studies comparing the new product with the reference product. Facilities that manufacture biosimilar products must also meet FDA standards.
The FDA approved its first biosimilar medication in the spring of 2015. The product, filgrastim (brand name Zarxio), is used to help prevent infection in cancer patients. The new biosimilar is considered highly similar to the reference product, also called filgrastim but with the brand name Neupogen.
The Patient Perspective
All conventional medications, biological products and biosimilars used in the US must be approved by the FDA. Once approved, biosimilars can be prescribed in the same way conventional medications are.
From a patient's perspective, there's little to no difference between these treatment options. In fact, the two are used interchangeably in many cases. In that way, biosimilars mimic generic drugs, which can also be used interchangeably with brand name drugs.
As with any medication, patients should follow directions given to them by their doctors and report any side effects they experience.