Drug development is an expensive and laborious process for drug companies, and involves conducting years of research in the lab, followed by years of clinical trials with patients, before a drug gets through the FDA review and approval (or rejection), and then onto the market. This results in a price tag on a newly FDA-approved drug that is very high when it finally gets to patients.
The access to care and the overall cost of care are crucial issues that affect patients with cancer and their treatment. Biosimilars are expected to reduce costs and improve the access to drugs for patients with cancer.
Biosimilars are similar to “biologic” drugs. Biologic drugs are made from a variety of living and natural sources, such as viruses, proteins, cells and tissues, or complex combinations of different substances, used for treating or preventing disease in humans. Biologic drugs currently used for cancer treatment include vaccines, monoclonal antibodies, and cellular therapies, and the majority of the drugs are very expensive.
In 2009, worldwide sales of biologic drugs accounted for more than half of drug expenditures, which was $99 billion.1 Worldwide, sales and use of biologic drugs in cancer and in other areas, such as rheumatology, immunology, and neurology, are expected to increase dramatically and could rise by 70% by 2025.2
Some common biologic drugs used for the treatment of patients with cancer include Arzerra (ofatumumab), Avastin (bevacizumab), Bexxar (tositumomab), Campath (alemtuzumab), Erbitux (cetuximab), Herceptin (trastuzumab), Mylotarg (gemtuzumab), Neulasta (pegfilgrastim), Rituxan (rituximab), Vectibix (panitumumab), and Zevalin (ibritumomab).
What Are Biosimilars?
Biosimilars are synthetically manufactured drugs that are very similar to our already FDA-approved biologic drugs, but they cost less than the original biologic drug, which is called the “reference drug.”
It is expected that biosimilars will be significantly less expensive than the original reference drugs, but currently biosimilars are only about 10% to 15% less expensive.
The FDA defines biosimilars as a “biologic product that is highly similar to its reference [original already approved biologic] product, notwithstanding minor differences in clinically inactive components and having no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency of the product.”3
Many biologic drugs, such as Avastin, Rituxan, Herceptin, and Neulasta, are nearing the end of their patent-protection period, meaning that more drugs using their active ingredients can be created. The impending patent expiration dates for these and for some other biologic drugs have triggered interest in developing less expensive, biosimilar drugs.
The Biologics Price Competition and Innovation Act was legislated in 2010 under the Affordable Care Act. This act created a quicker drug approval process by the FDA for biologic drugs that are demonstrated to be biologically similar (“biosimilar”) to an FDA-approved biologic drug. At present, investigational drugs can be considered biosimilar if the evidence shows that the drug is very similar to existing FDA-approved biologic drugs.
Reduced Cost: The First Cancer Biosimilar
In 2015, Zarxio (filgrastim-sndz) was the first biosimilar to be approved by the FDA and become available for patients in the United States. Zarxio is a biosimilar to the biologic drug Neupogen (filgrastim), and costs about 15% less.4 Zarxio can now be used instead of Neupogen for the treatment of patients with neutropenia (a condition associated with many types of cancer).
Although biosimilars are just becoming available in the United States, more than 19 biosimilar drugs have already been approved in Europe. The surge in interest to develop biosimilars is largely thanks to their reduced cost to patients, which is the means to decrease healthcare costs in the United States and worldwide.
Current government legislation in the United States supports the development of biosimilars. The use of biologically similar drugs (that is, biosimilars) in the treatment of cancer can dramatically reduce the costs to the patient and the U.S. healthcare system as a whole.
Improving Patient Access to Care
Oncology navigators play a key role in assessing and addressing barriers to care for patients with cancer. Lack of access to care, and the cost of care, are key barriers to cancer treatment and can prevent patients from getting the treatment they require. Biosimilar development offers possible solutions to those barriers.
The Role of Navigators
Navigators need to be aware of the differences in the production and approval process of biosimilars, and how this can affect patient care. As advocates and educators for their patients, navigators need to know whether the patient is receiving a biosimilar instead of a biologic drug, if a biosimilar is available.
To help navigators and other providers learn about the new approval pathway for biosimilar drugs and make informed decisions when considering the use of a biosimilar drug by a patient, the FDA has developed a new continuing education course, which is recommended for all navigators (see Patient Resources box).
- Walsh G. Biopharmaceutical benchmarks 2010. Nat Biotechnol. 2010;28:917-924.
- Jeske W, Walenga J, Hoppensteadt D, Fareed J. Update on the safety and bioequivalence of biosimilars-focus on enoxaparin. Drug Healthc Patient Saf. 2013;5:133-141.
- 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 January 29, 2017.
- Hirshier B, Sheilds M. Novartis launches first U.S. ‘biosimilar’ drug at 15 percent discount. Reuters. September 3, 2015. www.reuters.com/article/us-novartis-drug-idUSKCN0R30C220150903. Accessed March 20, 2017.
FDA Overview of Biosimilar Products
Information for Consumers (Biosimilars)