In 1984, Congress passed what is commonly referred to as Hatch-Waxman, a bill intended to lower the cost of prescription drugs by making generic versions available after an exclusivity period. However, one group of medicines, called biologics, was excluded from the bill. Many of the medicines used to treat colon cancer, such as Avastin and Erbitux, are biologics and so there are not lower cost versions available; however, that may be about to change.
First, what are biologics and why don’t they have generic versions? Drugs are essentially chemicals synthesized from other chemicals, so a company can make them using the same process. The Food and Drug Administration (FDA) will allow a company to make a generic version of a name brand drug provided they show that roughly the amount of active ingredient is the same as the approved name brand. Biologics, as the name suggests, are not chemicals, but are derived from living cells. In simple terms biologic medicines are literally “grown and harvested” from a line of living cells. So you can’t make a generic version of a biologic because you don’t have the original line of living cells.
In an effort to lower the cost of biologic medicines, the Affordable Care Act included a provision for the FDA to approve what are called “biosimilars.” These are biologics that the FDA deem “highly similar” in that they have the same method of action, route, dosage, etc. On March 6, 2015, the FDA approved the first biosimilar Zarxio, which is a biosimilar version of Amgen’s Neupogen. It is likely we will see other biosimilars in the near future; for example AstraZeneca is seeking to develop a biosimilar to Avastin with a Japanese company. Biosimilars should be less expense than the innovator medicine, but don’t expect generic-like cost savings. Biologics are incredibly complex and expensive to produce—some estimates suggest biosimilars will be around 20 to 30 percent less than the original biologic.
The Colon Cancer Alliance welcomes biosimilars as an option to reduce costs, but believes that regulators, payers, physicians and patients must be vigilant to ensure these medicines are both effective and safe; specifically we recommend:
- Naming – for patient safety it is vital that biosimilars are clearly distinguishable; this will avoid errors in prescribing, dispensing and tracking any adverse events. We applaud the FDA for last month proposing a naming system using a unique four letter suffix.
- Pharmacovigilance – is a system for tracking how a medicine works in the real world both in terms of efficacy and safety. Unlike the approval of the name brand in which extensive clinical trials were conducted, biosimilars are approved without clinical trials. As such, manufacturers of biosimilars should have a tracking system in place to ensure their biosimilar works just as well as the name brand.
- Physician Notification – with generics, pharmacies routinely switch from name brand and between different generic manufacturers. In fact it isn’t unusual for patients to have different colored pills in the same prescription bottle as the pharmacy buys from different generic manufacturers based on who offers the best price. It is critical for both efficacy and safety that this practice not occur with biosimilars. Pharmacists must be required to notify your doctor prior to switching to a biosimilar or among different manufacturers of biosimilars. The Colon Cancer Alliance opposes all legislation in which a pharmacist may substitute biosimilars without your doctor’s prior approval. You and your doctor, not the neighborhood pharmacist, are responsible for selecting the most appropriate medicine.
As always, we encourage you to Speak Up, Speak Out—leave a comment and let us know what you think.
Speak Up, Speak Out is an advocacy series where we bring you the information you need to know every third Tuesday of the month. Don’t forget, the Colon Cancer Alliance serves as a source of information about colon health. If you have questions or are in need of support, please contact our free Helpline at (877) 422-2030. We’re here to help!