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In 2014, Americans spent $374 billion on medicine.* Such a high expenditure on pharmaceuticals can burden patients and insurers alike. To help lower costs, doctors and nurse practitioners prescribe generic versions of drugs that are no longer protected by patents. But in the case of biologic medicines, there is no way to make an exact replicate and thus no way to make a generic version. This is a problem because many biologics are exceptionally expensive. Fortunately, there’s hope. Thanks to recent U.S. Food and Drug Administration (FDA) rulings, biosimilars are poised to replace name-brand biologics with lower-cost alternatives.
Biologic medicines rely on biological material. They encompass a wide range of treatments including vaccines, allergenics, gene therapies, tissue therapies, and blood components. All biologics are isolated from natural, biological sources. Because of this, they are complex in nature and not easily identifiable. Additionally, many are produced using cutting-edge biomedical technology that adds another layer of complexity.
While both biologic medicines and conventional medicines receive patent protection for a set duration, once those patents expire competing companies can only make generics of conventional medicines. That’s because conventional medicines are typically chemically synthesized. If you know the formula, you can manufacture an exact replicate of the drug. Biologics are different. The complexity of their structures and production makes it impossible to produce an exact replicate.
In short, a biosimilar is a “generic” biologic medicine that is highly similar to the brand-name drug, but not produced as a chemical replicate. Even though there may be variances at the structural or production level, biosimilars work just like their brand-name counterparts, providing the same strength and dosage method while avoiding any clinically meaningful differences. To the consumer, a biosimilar will seem identical to the name brand.
Until the FDA began approving biosimilars, the expiration of a biologic medicine patent didn’t result in the same lowering of costs typically seen once a conventional medicine’s patent expires. This is because the structure and production of biologics is so complex that it was impossible for a second company to produce an exact replicate. The FDA’s current rules on biosimilars circumvent that problem by allowing a competing medicine to be an all-but-exact replicate. In this way, competition can enter the biologic medicine marketplace. As companies compete for market share, prices are likely to drop.
Biologics and biosimilars demonstrate how quickly medical knowledge is evolving. If you work in medicine and want to improve your ability to understand all the new developments and how they can help patients, you should consider earning a Master of Science in Nursing (MSN). An MSN degree can give you the advanced knowledge you need to keep up with the latest in medical advancements. In addition, earning your master’s in nursing can help you become a nurse practitioner, which could allow you to work with biologic medicines.
One of the best ways to earn your MSN degree is through an online university. By enrolling in an online MSN program, you can continue working at your current job while you earn your degree. You can even enroll in an RN to MSN online program, allowing you to move from your RN to a BSN to an MSN at a faster pace than earning one nursing degree at a time. Thanks to online education, earning a master’s degree in nursing is more convenient—and possible—than ever before.
Walden University is an accredited institution offering an online MSN program. Expand your career options and earn your degree in a convenient, flexible format that fits your busy life.
*A. Sifferlin, Americans Spent a Record Amount on Medicine in 2014, Time Health, on the Internet at www.time.com/3819889/medicine-spending.
Walden University is accredited by The Higher Learning Commission, www.hlcommission.org.