Sixth Issue, Series Two
Understanding the Value of Biosimilars in Oncology
We all go to our local pharmacy to get prescriptions filled for ourselves or a loved one. We usually notice, primarily based on the copayment, whether the prescription drug we are getting is a trade name we may see in a television commercial or it is a generic drug. How? By the amount of the copayment. Our money goes much further when we get a generic form of a drug, as the copayment is commonly 75% less than that for the real McCoy (ie, trade name drug). People question why there is such a huge price difference between the “same thing,” and they also wonder whether the drug with the long confusing name is as good as the brand advertised on television.
Pharmaceutical companies spend millions and millions of dollars conducting research focused on drug development to get a new innovative drug, carefully and tediously researched in the lab, into human clinical trials to eventually get it approved and to the market. The time line is commonly 15 years or longer. More importantly perhaps, most of the drug development research never makes it anywhere, despite hundreds of millions of dollars being spent trying to create a drug that will be of value to those who need it. This results in the price tag on a newly FDA-approved trade name drug being very high when it finally gets to market. It is the only way for the pharmaceutical companies to attempt to recover their investments as well as offset the losses they have experienced on all the other drug research that met with a dead end. At present there is no alternate system to recover the exorbitant expenses incurred through bench and human research.
With our healthcare economic system where it is today (ie, incredibly top-heavy in expenditures on medications compared with other healthcare expenses), we have to begin embracing the concept and benefits of what are called “biosimilar” products. These are synthetically manufactured drugs that are highly similar to our already FDA-approved biological products but cost a tiny percentage of their original innovative versions. The similarity is despite a few minor differences in clinically inactive components, and if there are no clinically meaningful differences in safety, purity, and potency between the biosimilar and the approved biological product,1 then it makes sense to use the biosimilar option whenever possible. The biosimilar drugs are not exactly the same as the innovator products but are considered biologically and clinically comparable.
This final issue in the series of Conquering the Cancer Care Continuum provides you insight into issues that pharmacologists and pharmacists face related to providing these types of drugs and understanding the differences, if any, between the original innovator drugs and the new Memorex versions of them. You will learn the dollars and cents associated with this challenge and how it impacts the future of oncology care in the United States. There is also a thought-provoking article about these drug comparisons and the complexities that nurses and other healthcare providers face in trying to explain to patients why they are receiving what they believe to be “brand X,” whether it is really as good as its original form, and why they should be accepting the biosimilar drug.
Research has by no means ended when it comes to this debate. There will always be ongoing research to validate the accuracy of the effectiveness as well as side effect comparisons long-term, going well beyond 5 years of study.
If we don’t embrace the value of these synthetically created products, soon we will not be able to afford treating patients with cancer no matter what drugs are or aren’t available. Recognizing that the incidence of cancer continues to grow steadily and will continue to do so with baby boomers now in midlife, and our current healthcare economic structure being incredibly out of control, we need to look at this as being one of the solutions to reining in cost so we have the drugs available and can afford to use them to get more people to become cancer survivors.
- US Food and Drug Administration. Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. 2012. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed July 31, 2013.
CJ is a 62-year-old female beginning chemotherapy with doxorubicin and cyclophosphamide for stage III breast cancer. To minimize the risk of neutropenia-associated complications, it is planned for CJ to return to the clinic daily following chemotherapy for injections of a colony-stimulating factor (CSF) until her absolute neutrophil count exceeds 10,000 [ Read More ]
In April 2011, the National Comprehensive Cancer Network (NCCN) convened a summit of key stakeholders regarding the issues surrounding biosimilars in oncology care. The working group subsequently published a sentinel white paper outlining the regulatory, scientific, and patient safety issues surrounding the development and expansion of biosimilars in oncology care.1 [ Read More ]