For the first time in history the FDA has approved the use of biologic drugs in the United States. The FDA’s recent decision to approve a cheaper, biologic form of cancer therapy now opens the door for other biologic drugs to enter the U.S. market.
More importantly, the FDA’s action also changes the future of medicine and health care costs for both patients and pharmaceutical companies.
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Biologics are genetically engineered proteins derived from human genes and made from living organisms rather than synthesized from chemicals. Science has learned how to use these genes to target specific components of diseases and the organs involved rather than giving a patient drugs which affect the entire body.
For instance, biologic drugs can be used to treat arthritis. The biologic only targets the parts of the body’s immune system that causes inflammation, which is a major component of arthritis. The rest of the body isn’t impacted by the biological medication.
The major difference in treatment is that biologics must be inhaled, injected or infused into the body to be effective. If taken in pill form they are destroyed by the body’s stomach acid and are rendered ineffective. Science is working on ways to bypass the stomach acids so biologics can be taken in pill form, but for now injections are the primary delivery method.
Biologics can also be paired with oral medication as well to create a more effective overall treatment plan. Although biologics are sometimes slightly more expensive than pills, they are also a more effective treatment. A more effective and shorter-term treatment leads to lower costs and better health over time. Depending on the type of disease, biologics can be much less expensive than traditional treatments. Prices of biologics are expected to drop over time as well.
Why Are Biologics Better?
Biologics are better for many patients because they have fewer side effects and health risks for the patient. Most side effects are rash and redness at the site of the injection. They are more effective treatments overall because they target the body system components associated with the disease and not the entire body. Biologics are typically taken less often than pills, making treatment easier for patients.
The Drawbacks Of Biologics
The two primary downsides to biologics are the cost of making them, and the delivery method. Since biologics are made from living organisms, they are difficult and expensive to make. They’re also harder to take since they must be injected, infused or inhaled. Patients will have to get used to giving themselves injections, and inhaling or receiving an infusion of medicine rather than taking a pill.
Scientists are working to make it possible to take biologics in pill form, but until then, injections are one of the few downsides of biologic drugs.
Patients may be reluctant to take biologics because they are required to give themselves injections. Even though millions of diabetics already inject insulin, and even more patients with allergies and other conditions also give themselves daily injections, doctors believe patients may hesitate at daily or monthly injections for treatment of cholesterol, migraines, and other health conditions.
What Does The FDA Approval Mean To Me As A Consumer?
The FDA’s approval means opening the door to allow more biologic drugs into the U.S. That means a savings of 5 to 6 billion dollars a year in drug care costs, lower cost for medicine for many consumers, and more competition among pharmaceutical companies, which also lowers medicine costs. Biosimilar drugs, which are similar to biologic drugs, cost up to two-thirds less than the biologic drug, reducing health care costs even more—up to 90 percent by some expert assessments. That approval also means better drugs, fewer side effects and better health care in the years to come.
Clinical Trials
At Chase Medical Research, we are constantly enrolling in clinical trials for a variety of conditions and medications. If you're interested in participating in a clinical trial or are curious if a clinical trial is right for you, don't hesitate to contact us.
