Understanding biologic and biosimilar medicines
While most medicines are synthesized from various chemicals to produce pills or capsules, biologic medicines are manufactured using living cells that have been engineered to produce therapeutic proteins in large quantities. The living cells can be derived from micro-organisms (bacteria and yeast), plant cells or animal cells (mammalian). Biologics and biosimilars are injectable medicines as opposed to pills or capsules.
Chemical medicines are made and reproduced by following a recipe. Biologic and biosimilar medicines, however, must be grown through an intricate and delicate process. Biologic drugs are more advanced and are designed to target and treat disease at its source.
Unlike conventional chemical medicines from which generics can be identically duplicated, no two biologic medicines can be exactly the same — just as no two fingerprints are exactly alike.
This means that although biosimilars are highly similar to their original biologic counterpart, they won’t be identical, and a patient’s response may be different from one treatment to the other. To provide the highest quality care, doctors must know exactly what drug the patient received at the pharmacy.
In Nevada, thousands of families live with serious diseases — from cancer, arthritis and multiple sclerosis to diabetes, heart disease, lupus and other autoimmune conditions.
Today, advances in modern medicine — specifically in biological medicines — are providing hope for patients who are eager for effective treatments that allow them to live healthier, happier and longer lives.
The mission of the International Cancer Advocacy Network is to extend life with the highest quality in mind. Increasingly, we are focusing on biologics.
Biologics are drugs that come from biological sources. Herceptin, Rituxan, Avastin, Aranesp, and Epogen are some biologics for cancer that you may have heard of. Others, such as Humira, Enbrel and Remicade, are used to treat arthritis.
Biologics can have stunning success — two of the longest remissions we have seen in Stage IV cancer patients (the most serious stage) were due to a biologic. My mother survived 16 years with metastatic breast cancer thanks to a biologic. In another case, a gastrointestinal cancer patient had been written off by a major cancer center and told there was no hope. That patient also benefited from a biologic which ushered a shift in oncology practice and lived 14 years (dying of an unrelated illness) with a very high quality of life.
As patents for brand biologics expire, biopharma companies are developing copies of interchangeable biologics, called biosimilars — which will likely reduce costs, just as generics do. Generics, however, are exact chemical copies of the original drugs. Biologics are derived from living cells, and are more advanced than chemical-compound drugs because they target and treat the disease at its source. Biosimilars can be slightly different from the original brand biologics due to the complexity of the manufacturing process, transportation or handling. These differences mean either product (original or biosimilar) could produce adverse reactions in some patients.
The advancements are great but we must protect patient safety. Nevada needs to update its laws to ensure that patients, pharmacists and physicians are all in sync where biologics are concerned.
In the last few years, 26 states and territories passed legislation to allow biosimilar medications, providing patients with crucial, affordable treatment options as they come onto the market.
We need to support similar legislation in Nevada that permits the substitution of biosimilars for brand name biologic medicines. Such legislation is needed because while the Food and Drug Administration governs the approval and designation of interchangeable biologic (biosimilar) products, dispensing of all biologics is governed by state law under pharmacy regulations.
The proposed biosimilar legislation, sponsored by Assembly Majority Floor Leader Teresa Benitez-Thompson, D-Reno, includes five primary principles:
— Substitution should occur only when the FDA has designated a biological product as interchangeable.
— The prescribing physician should be able to prevent substitution, i.e., order to fill “as prescribed.”
— The pharmacist should communicate to the patient that a substitution was made.
— Prompt communication is required from the pharmacist to the prescribing physician after a substitution occurs.
— A record of the substitution must be kept by the pharmacy and the physician for a set period of time to ensure a complete medical record for the patient.
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To monitor adverse reactions, your physician needs to know what you’ve been given. An incomplete record could undermine your treatment. Every patient (and every physician) I have talked with agrees. As one of ICAN’s cancer survivors, Joan Golden of Las Vegas, put it, “I would be appalled if my physician was kept in the dark about the exact drugs I had been given.”
It’s up to Nevada legislators to seize an incredible opportunity to pass legislation that will improve the lives of thousands of people across the state, protect patient safety and reduce health care costs.
Marcia K. Horn, J.D., is president and CEO of ICAN, the International Cancer Advocacy Network. Email her at [email protected].