One of the least well-known but most promising areas of drug research is the creation of generic biologic medicines, or biosimilars. These drugs have great potential and often offer the best treatments for serious diseases such as cancer, HIV/AIDsS, rheumatoid arthritis, and heart disease. However, our current drug system is not adapted for them, and needs to be modified for our new era.
What exactly are biologic medicines and biosimilars? Biologics are medicines extracted from a variety of natural sources--from humans, animals, or microorganisms. They include a great number of products such as vaccines, blood components, gene therapy, tissues, and recombinant therapeutic proteins. Biologics are the cutting edge of current research, but they are often tremendously expensive, sometimes as much as thousands of dollars per treatment. That renders them unaffordable for all but the wealthiest of patients.
Enter biosimilars--biologic medicines that are approved by on data showing they are very similar to existing brand name biologics (called the reference products). Companies that make biosimilars must prove that their new drugs are just as safe and effective as the reference products. Some biosimilars can be designate interchangeable with the reference products, which means they can be substituted for the brand name biologics by pharmacists without needing the intervention of prescribing doctors. And since biosimilars rely on information from the original drugs and don't have to go through expensive new clinical trials, they are far cheaper than the originally brand biologics.
And this area is expanding. Over 200 biologic medicines are now approved for use in the United States. Sales of these biologics have gone up 65% since 2011, and since they are quite expensive, they account for a lot of prescription drug spending. Biosimilars are essentially generic versions of those medicines, and like other generics, they will reduce costs and therefore improve patient access to needed medicines. Their development should be encouraged.
Fortunately, the Food and Drug Administration (FDA) is moving to correct the problem. It is now providing guidance documents that the steps that manufacturers of biosimilars must take to get their medicines approved.
Moreover, various states have substitution laws, which determine when generic medications can be substituted for more expensive brand medications. However, these substitution laws were not written with biosimilars in mind. States must therefore update their substitution laws to allow for biosimilars to be used in place of brand biologics, which will save states quite a lot of money.
If affordable biosimilars are encouraged and made widely available, an additional 1.2 million patients could benefit form these medicines over the next decade. And women, the elderly, and low-income Americans would be disproportionately among those helped. Policymakers should act quickly to promote biosimilars--drug prices are already far too high, and since legislation is gridlocked in Congress, every little bit helps.