Biosimilars for Cancer Treatment – HealthyWomen

How is a biosimilar different from a biologic versus a generic drug?

Biologics are drugs made from living cells or organisms. That’s why they are called biological – bio meaning living cells. Some examples of biologics are gene therapies, stem cell therapies, monoclonal antibodies, and recombinant proteins.

These drugs are used to treat chronic conditions, including autoimmune disorders such as rheumatoid arthritis, lupus, and Crohn’s disease, as well as some cancers.

A generic drug is an exact chemical copy of a drug, with identical active ingredients. It is not possible to create an exact copy of a biological material as it is made from a living source, so biosimilars are as close as you can get. There are slight 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 allow a biosimilar on the market unless it sees data showing safety and efficacy. After the drug is approved, they continue to monitor it to make sure it is safe and working as it should.

Is the FDA approval process different for a biosimilar?

The approval process for a biosimilar is an abbreviated process. When the FDA decides whether to approve a biosimilar, it doesn’t look at how chemically close the drug is to its biological model. They only look at 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 a bit more expensive to develop. Since biosimilars are based on a biological as opposed to being invented from scratch, they don’t cost as much to make. These savings are often passed on to patients.

Having a cheaper but equally effective alternative to biologics means we can offer these treatments to more patients and start them sooner — which can ultimately lead to better outcomes.

Read: Understanding biosimilars: Better access to advanced medicines >>

Is there any difficulty with insurance coverage for biosimilars?

No. Insurance companies now understand the role of biosimilars and believe that everyone (including insurers) benefits from having more treatment options. In my experience, they are very comfortable with covering biosimilars, but which biosimilars are covered will vary depending on a person’s insurance plan.

How do cancer biosimilars work?

Biosimilars have ushered in an era of expanded possibilities for cancer treatment. The type of biosimilar now most commonly used to treat cancer is monoclonal antibodies. These drugs work by binding to a specific protein on a cancer cell, helping to block signals for cancer to grow.

One is called bevacizumaband is used to treat metastatic colon cancer, lung cancer, and kidney cancer. Others we use are trastuzumab for the treatment of HER2-positive breast cancer and rituximab for the treatment of non-Hodgkin’s lymphoma.

We also use biosimilars to provide supportive care to cancer patients. One called epoetin helps anemia caused by chemotherapy, and another called filgrastim used for neutropenia (low white blood cell count).