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A biosimilar is a medicine that is similar to an existing branded biological medicine (a medicine made from living organisms and cells). Although biosimilars are not identical copies of biopharmaceuticals, they are very similar and work in the same way.
Like biopharmaceuticals, biosimilars have many different uses, including for the treatment of certain types of cancer.
We spoke with Gury Doshi, MD, medical director of Texas Oncology-Houston West and chair of the US Oncology Network’s Pharmaceuticals and Therapeutics Committee, to learn more about these promising treatments.
How do biosimilars differ from biopharmaceuticals and what happens with generics?
Biopharmaceuticals are medicines made from living organisms and cells. That’s why they are called biopharmaceuticals, bio means living cells. Some examples of biopharmaceuticals include gene therapies, stem cell therapies, monoclonal antibodies and recombinant proteins.
These medications are used to treat chronic diseases, including autoimmune diseases such as rheumatoid arthritis, lupus, and Crohn’s disease, as well as some types of cancer.
A generic is a chemically exact copy of a drug with identical active ingredients. It is not possible to create exact copies of biopharmaceuticals because they are made from living sources. Therefore, biosimilars are the best option available. There are minor differences between both types, but not enough to affect their structures or functions.
Read: Understanding Monoclonal Antibodies >>
Are biosimilars safe and effective?
Yes, completely. The FDA [Administración de alimentos y medicamentos] would not allow a biosimilar to be marketed unless data are analyzed to demonstrate its safety and effectiveness. After the drug is approved, the FDA continues to monitor it to make sure it is safe and works properly.
Is the FDA approval process different for biosimilars?
The approval process for a biosimilar is a shortened process. When the FDA decides whether to approve a biosimilar, it does not examine how chemically similar the drug is to the biodrug on which it is based. All that is analyzed is whether the biosimilar is safe and effective.
Do biosimilars have any advantages?
The fact that biopharmaceuticals are made from living organisms and cells makes them special, but also makes them more expensive to develop. Because biosimilars are based on biopharmaceuticals and are not invented from scratch, the manufacturing costs are not as high. Savings are passed on to patients.
By having a cheaper but equally effective alternative to biopharmaceuticals, we can offer these treatments to more patients and reach them more quickly, ultimately leading to better clinical outcomes.
Read: Understanding Biosimilars: Better Access to Advanced Medicines >>
Are there difficulties with insurance coverage for biosimilars?
No. Insurance companies now understand the role of biosimilars and know that everyone (including insurers) benefits from more therapeutic options. In my experience, they do cover biosimilars, but coverage for each biosimilar depends on the individual’s insurance plan.
How do biosimilars work against cancer?
Biosimilars have ushered in an era of more options for cancer treatment. The biosimilars used for most cancer treatments today are monoclonal antibodies. These drugs work by binding to certain proteins on cancer cells and blocking signals that encourage cancer to spread.
One is called bevacizumab and is used to treat metastatic colon, lung and kidney cancer. Other options include trastuzumab to treat breast cancer with a HER2 gene mutation and rituximab to treat non-Hodgkin lymphoma.
We also use biosimilars to offer complementary treatments to cancer patients. One called epoetin is useful for anemia caused by chemotherapy, and another called filgrastim is used for neutropenia (low white blood cell count).
What should I ask my cancer care team about biosimilars?
Questions you might ask include:
- What biodrug is this biosimilar based on?
- Is there a difference in the dosage or frequency of administration?
- Are there any side effects that are unique to this biosimilar?
- Will this biosimilar be administered in the same way as the biomedicine (in IV form or by injection)?
Our job as healthcare providers is to ensure that our patients know that there are treatment alternatives for them and that they have all the information they need about those alternatives.
Is there anything else you would like to tell people about biosimilars for cancer treatment?
Biosimilars have increased the availability of cancer treatment options for patients in the United States and around the world. In fact, these are options that are not given enough attention in cancer treatment today.
This educational resource was created with the support of Sandoz.
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