A biosimilar is a medicine that is similar to an existing branded biological medicine (a medicine made from living cells and organisms). Although biosimilars are not identical copies of biologics, they are very similar and work in the same way.
Like biologics, biosimilars have many different uses, including for the treatment of certain types of cancer.
We spoke with Gury Doshi, MD, medical director at Texas Oncology-Houston West and chair of the Pharmacy and Therapeutics Committee of the US Oncology Network, to learn more about these promising treatments.
How does a biosimilar differ from a biologic and a generic?
Biologics are medicines made from living cells or organisms. That’s why they are called biologics – bio means living cells. Some examples of biologics include gene therapies, stem cell therapies, monoclonal antibodies, and recombinant proteins.
These medicines are used to treat chronic diseases, including autoimmune diseases such as rheumatoid arthritis, lupus and Crohn’s disease, and some types of cancer.
A generic is an exact chemical copy of a drug with identical active ingredients. It is not possible to make an exact copy of a biologic because it comes from a living source. Therefore, biosimilars are as close as it gets. There are minor differences between the two, but not enough to affect their structure or function.
Read: Understanding Monoclonal Antibodies >>
Are biosimilars safe and effective?
Yes, absolutely. The FDA will not bring a biosimilar to market unless there is data showing safety and effectiveness. Even after the drug is approved, they continue to monitor it to make sure it is safe and works properly.
Is the FDA approval process different for a biosimilar?
The approval process for a biosimilar is a shortened process. When the FDA decides whether to approve a biosimilar, it does not consider how chemically similar the drug is to its biological counterpart. They simply check whether the biosimilar is safe and effective.
Are there advantages to biosimilars?
The fact that biologics are made from living cells and organisms is what makes them special, but also makes them somewhat more expensive to develop. Because biosimilars are based on a biologic and are not invented from scratch, they are not that expensive to produce. These savings are often passed on to patients.
Because we have a cheaper but equally effective alternative to biologics, we can offer these treatments to more patients and get them started more quickly – which can ultimately lead to better 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 realize that everyone (including insurers) benefits from more treatment options. In my experience, they are very happy with biosimilar coverage, but which biosimilars are covered depends on a person’s insurance plan.
How do biosimilars work on cancer?
Biosimilars have ushered in an era of expanded cancer treatment options. The type of biosimilars currently most commonly used for cancer treatment are monoclonal antibodies. These drugs work by binding to a specific protein in a cancer cell, helping to block signals for cancer growth.
One is called bevacizumab and is used to treat metastatic colon cancer, lung cancer and kidney cancer. Others we use include trastuzumab to treat HER2-positive breast cancer and rituximab to treat non-Hodgkin lymphoma.
We also use biosimilars to provide supportive care for cancer patients. One called epoetin helps with anemia caused by chemotherapy, and another called filgrastim is used for neutropenia (low white blood cell count).
What questions should I ask my cancer care team about biosimilars?
Questions you might ask include:
- What biological drug is this biosimilar based on?
- Is there a difference in 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 biologic (by infusion or by injection)?
It is our job as providers to ensure that our patients know they have choices in their care and that they have all the information they need about those choices.
Is there anything else you would like to tell people about biosimilars for cancer?
Biosimilars have opened up cancer treatment options for patients not only in the United States but around the world. They truly were the unsung heroes of modern cancer treatment.
This educational resource was created with the support of Sandoz.
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