You may have heard the term “biosimilars” discussed in the news or the office and wondered what it means. Don’t worry, you’re not the only one. Biosimilars recently became a popular topic after 2 biosimilar drugs were approved for use in the United States. So, what are biosimliars and why should we care? Let’s learn a little bit more about this innovative medical treatment and how these drugs could have a big impact on drug costs and our healthcare system.
Before we get into the details of biosimilars, let’s discuss biologics, or drugs that biosimilars intend to mimic. Biologics is a drug classification that describes variations of living proteins specifically made or programmed to counteract disease. Biologics have been around for 33 years and differ from many traditional treatments by targeting the cause of a disease rather than treating just the symptoms. Biologics are effective against diabetes, cancer, autoimmune conditions like rheumatoid arthritis, multiple sclerosis, Crohn’s disease and a variety of other conditions.
A biosimilar is a pharmaceutical drug that is almost an identical copy of a biologic manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires. It’s important to understand that biosimilars are exactly that – similar to the original biologic. Why aren’t they identical? Because biologics are complex, living cells and that means they can’t be exactly replicated like generic drugs.
So Biosimilars and Generic Drugs aren’t the Same Thing?
Nope, these are two separate drug forms. Generic drugs are approved after the brand-name drug’s patent has expired, and have the same active ingredient, strength, dosage form, route of administration, and bioequivalencey as the brand-name drug. These are known as small molecule drugs because their chemical make-up isn’t as complex as biologics. Since biologics are complex mixtures of molecules, they are harder to clone than a small molecule drug.
Confused? No problem, here’s more information about the differences between generic drugs and biosimilars:
|Structure||Simple and well-defined||Complex with potential structural variations|
|Manufacturing||Predictable chemical process to make identical copy||Specialized biological process to make similar copy|
|Complexity||Easy to fully characterize||Difficult to characterize due to heterogeneity|
|Stability||Relatively stable||Sensitive to storage and handling conditions|
|Adverse Immune Reaction||Lower potential||Higher potential|
|Approval Requirements||Small clinical trials in healthy volunteers||Large clinical trials in patients|
Why Are Biosimilars so Popular?
So, you’ve heard about biosimilars and wondered why the term has attained buzzworthy status. We’re here to break down the reasons for this rise in popularity:
1. Biosimilars recently became available in the U.S.
The FDA recently demonstrated its willingness to approve biosimilars as long as there are “no clinically meaningful differences in terms of safety and effectiveness from the reference product [the biologic].” The first biosimilar approved for use in the U.S. was Zarxio (a medication that helps patients receiving chemotherapy make white blood cells, preventing infections common among cancer patients) in the spring of 2015. Zarxio has the same active ingredient as a biologic called Neupogen, and was shown to be just as safe and effective.
2. Biosimilars are available at lower costs
Once the patent on a biologic has expired, its formula is no longer protected. So other companies can release a drug with the same chemical recipe which drives the cost down. Some estimate that they could save U.S. consumers $250 billion over the next decade.
That being said, the steep price differences that we are accustomed to seeing with generic vs. brand-name small molecule drugs won’t be replicated with biosimilars. This is because it takes more energy, time and money to make a biosimilar than it does to make a generic drug.
It’s likely that we’ll see many more biosimilars hitting the market in the U.S. over the coming years. Some worry about the safety and effectiveness of biosimilars, however, rest assured that since biosimilars are a complex and emerging drug classification, regulations on biosimilars will be complex and robust as biosimilars continue to develop.
Do you have experience with biosimilars? Tell us about it in the comments below!