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The medical marketplace is about to get bigger. The Food and Drug Administration (FDA) has approved a second biosimilar product—Inflectra (Infliximab-dyyb), a biosimilar to Remicade (infliximab)—and expects to approve other biosimilars in the future. The FDA approved Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), in March 2015.
What are biosimilars? To understand that it helps to first know what biological products (biologics) are, says Leah Christl, Ph.D., Associate Director for Therapeutic Biologics at FDA.
Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms such as yeast and bacteria.
“Biologics are different from conventional medications. Conventional medications—drugs—are generally made from chemicals, or chemically synthesized, and therefore their structure can be relatively easily defined,” Christl says.
Unlike conventional medications, biologics can’t be made by following a chemical “recipe.” “Biologics come from living organisms that are variable in nature. In addition, they are generally more complex and not as easy to define and characterize,” she adds. Because of that, developing biologics is a far more complex process than manufacturing drugs.
Just as it does for drugs, FDA rigorously and thoroughly evaluates a biologic’s safety and effectiveness before granting it licensure (approval). Currently, biologics are among the fastest growing segments of the prescription product market.
Christl says a biosimilar is a type of biologic that is highly similar to another, already FDA-approved biologic (known as the reference product).
“It is important to note that a biosimilar is not just like a generic drug,” she adds. “Because of the differences in complexity of the structure of the biologic and the process used to make a biologic, biosimilars are not as easy to produce as generics, which are copies of brand name drugs. A biosimilar is not an exact duplicate of another biologic; rather, a biosimilar is highly similar to the reference product.”
Before approving a biosimilar, FDA experts must also first verify that there are no clinically meaningful differences between the biosimilar and its reference product. In other words, it will work the same way as the reference product for its approved indications.
Also, the biosimilar must have the same strength and dosage form (for injection, for example) and route of administration as the reference product. The biosimilar must be manufactured following Current Good Manufacturing Practices.
“Patients can rest assured that they’ll be able to rely upon the safety and effectiveness of an FDA-approved biosimilar, just as they can rely on the reference product that the biosimilar was compared to,” Christl says. Like other biologics, biosimilars generally must be prescribed by a physician.
Inflectra is biosimilar to Remicade (infliximab). It’s approved for multiple conditions, including:
- Crohn’s disease
- ulcerative colitis
- rheumatoid arthritis
- ankylosing spondylitis
- psoriatic arthritis
- plaque psoriasis
The most common expected side effects of Inflectra are respiratory infections. These can include:
- sinus infections and sore throat
- stomach pain
Infusion reactions, which can happen up to two hours after an infusion of Inflectra, may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash and itching. Health care professionals are advised to review the labeling (prescribing information) of Inflectra for more detailed information, including information regarding approved indications and potential adverse reactions.
“Biosimilars are likely to create greater competition in the medical marketplace,” Christl says. This could not only increase treatment options for patients but also lead to less expensive alternatives to comparable products. With an increasing number of biosimilars on the market, consumers may expect to get equally safe and effective treatment, but at lower costs, she says.
Updated: April 7, 2016
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