Understanding Biosimilars

Biosimilars have potential advantages in treating cancer. They introduce competition into the drug development process, which can lead to cost savings for patients and increase the development of new treatments.

Drug Patents and Generics

When drugs are approved by the FDA (Food and Drug Administration), the company that developed the drug is normally given a patent. A patent is the exclusive right to produce the drug for a certain number of years. Patents are given in order to encourage pharmaceutical companies to research new medications.

Once the patent for a medication expires, other companies are allowed to produce similar medications with the same chemical make-up. In all important ways, these drugs are the same as the original and are called “generics.” Because multiple companies make these drugs, they often become cheaper. Usually, doctors will consider what generics are available when prescribing treatments.

Biologics and Biosimilars

Some medications are created from living things instead of purely chemical compounds. These may come from microorganisms, plants or animals and are called “biologics.” Most biologics are large and complex mixtures of molecules produced using cutting-edge technologies.

Biologics are also reviewed and approved by the FDA and given a patent. As with all medications, other companies are allowed to create similar biologics once these patents expire. However, with these drugs that come from living things, there is a key difference. The products from competing companies are allowed to be slightly different because they are made from a living organism.

Understanding Biosimilars

Biosimilars have potential advantages in treating cancer. They introduce competition into the drug development process, which can lead to cost savings for patients and increase the development of new treatments.

These medications that produce the same results as biologics are called “biosimilars.” Although they are not exact copies, they are expected to produce the same clinical results as the originals. They are considered the same in terms of safety, purity and potency.

Because biosimilars do not need to be exactly the same to be effective, this lends flexibility to the testing and patent processes. Like generic drugs, this can lead to less expensive treatments.

There are a number of biologics and biosimilars on the market now. These include allergy medications, vaccines, hormones and more. One especially important example are monoclonal antibodies. These are used in the treatment of many conditions, including breast cancer and lymphoma.

The Role of Biosimilars in Your Cancer Treatment

A doctor will often prescribe the generic version of a drug to save a patient money. The same is true with biosimilars, when they are available. If you have questions about generic or biosimilar versions of your medications, your doctors will be able to provide you with answers. Your pharmacist should also be able to answer questions when you pick up your prescription. They can tell you how the medication works, how it should be taken and the side effects.

Every insurance plan, including the Medicare Prescription Drug Plan, has a list of medications the plan covers. This is called a formulary. If the original medication is covered by the plan, the biosimilar will also be covered.

This is because the biologic and biosimilar have been approved by the FDA for the same indications.

If a biologic is included in your cancer treatment and a biosimilar becomes available, you will not automatically be placed on the new drug. However, a change should be strongly considered, as the medical profile is clinically the same and the cost is substantially different.

Any side effects from a biosimilar should be the same or similar to the original biologic, as their efficiency and safety profile are very similar.

Financial Resources

There are a number of financial aid organizations and patient assistance programs available to help with out-of-pocket expenses. Even with the availability of generics and biosimilars, the cost of cancer medication can be expensive. Members of your health care team, including your pharmacist, can be good sources of information about these resources.

Oncology social workers can also help. CancerCare’s oncology social workers are licensed professionals who counsel people affected by cancer, providing emotional support and helping people access practical assistance. Call 800-813-HOPE (4673) or visit www.cancercare.org for more information.

The CancerCare Co-Payment Assistance Foundation can also help with the cost of prescriptions for those who are eligible. For more information, call 866-55-COPAY (866-552-6729) or visit www.cancercare.org/copayfoundation for a list of covered diagnoses and requirements.

Edited by Jessica Richy, Pharm. D., R.Ph.