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Biosimilars and MS: Door Opens for New Treatment O

By Gay Falkowski

During the past three decades biologic drugs revolutionized the treatment of many chronic, disabling, and life-threatening diseases — including multiple sclerosis. Like most specialty drugs, they come with a steep price. Biologics cost more to develop and bring to market than conventional drugs because they are more complex, fragile, and difficult to manufacture. However, as patents on biologics expire, the door opens for potentially lower-cost versions of biologic drugs called biosimilars. 

The U.S. Food and Drug Administration approved the first biosimilar in March 2015. As of August 2018 only four out of a dozen approved biosimilars have launched in the U.S. None of the approved biosimilars are disease-modifying therapies for MS, and it’s unclear when a biosimilar DMT may become available. But it’s not too soon to begin learning the basics about biosimilars: 

What are biologics and biosimilars?
Biologic drugs contain one or more active substances made by or derived from a biological source such as cells and tissues. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances. Examples include monoclonal antibodies, therapeutic proteins, and vaccines. The first generation of a particular biologic drug approved by the FDA is known as the biologic reference product. Drugs modeled after biologic reference products are called biosimilars.

Why are some drugs called generics, and others are called biosimilars?
The type of drug used as the reference product determines whether the new product will be classified as generic or biosimilar. Typically, generics copy the formula of active, chemical ingredients used to make traditional small-molecule reference products. In contrast, biosimilars are based on large-molecule reference products drawn from natural sources and developed through a more complex procedure. 

How are the approved MS disease-modifying therapies classified?
The MS therapies classified as chemical medications include brand name drugs Aubagio, Copaxone, Gilenya and Tecfidera. The other MS therapies are classified as biologics or biological products. As of August 2018, the FDA has approved three generic forms of glatiramer acetate (Copaxone). No other generic DMTs are available at this time. However, many of the drugs prescribed to manage MS symptoms have generic equivalents.

Are biosimilars identical to their reference products (brand names)?
No, they are not exactly the same. “Biosimilar” means the biological product is highly similar to the reference product and there are no clinically meaningful differences between the biosimilar product and the reference product in terms of effectiveness, safety, purity, and potency. The biosimilar may contain minor differences in clinically inactive components. Also, biosimilar products may be approved for all or a subset of the same indications as the reference product. 

What is an interchangeable product? 
If a product has been determined to be interchangeable, then it is biosimilar to the reference product and will produce the same clinical result as the reference product in any given patient. Interchangeable also means the original biologic and the new biosimilar can be switched back and forth in patients without a risk of diminished safety or efficacy. No intervention from the prescriber is required to make the dispensing changes. 

Will biosimilars offer as much savings as generics?
It’s highly unlikely that biosimilars will be able to offer as much savings per product as generics. Like generics, biosimilars take a shortened pathway to approval by the FDA. Still, the approval pathway for biosimilars takes about eight years compared with about two years for generics. According to estimates, biosimilars will shave from 10 to 35 percent off the list price of the brand name drug. Generics typically reduce list prices by about 60 to 90 percent.

Do I have to meet any criteria before my doctor can prescribe a biosimilar?
The answer depends on your insurance company. Healthcare providers can prescribe biosimilar and interchangeable biological products just as they would prescribe other medications. However, the list of medications covered by insurance (called a formulary) varies according to the company and the plan you’re on. Sometimes insurance providers require you to try other drugs or satisfy certain requirements before they’ll authorize coverage. 

How can I find out if biosimilars become available for any of my prescription drugs? 
Ask your healthcare team to let you know you know when a biosimilar becomes available for your condition. Medication change is an important topic; you and your doctor will want to discuss the pros and cons before making a decision. While saving money is definitely a plus, cost is only one factor to consider while determining which treatment is best for you.