Multiple Sclerosis Centers of Excellence
Generic and Biosimilar Disease Modifying Therapies
Rebecca Spain, MD, MSPH, Mitchell Wallin, MD, MPH, Heidi Maloni, PhD, APRN, BC-ANP, MSCN, and Kathy Tortorice, PharmD, BCPS
The field of MS is seeing an explosion of new US Food and Drug Administration (FDA) approvals for MS disease modifying therapies (DMT). Some of these approvals are for generic and biosimilar versions of existing brand-name DMT raising questions among MS providers and Veterans with MS alike about what they are, why they exist, and when we may see them used for MS treatment in the VA.
The What
Generic medications are chemically identical copies of the original brand-name medications. Generics are commonly used when treating diseases like high blood pressure and high cholesterol because the medications for these disorders have a simple chemical structure and it is therefore easy to manufacture an exact copy of them. It is harder to create generics for some MS therapies for two reasons. One, because some DMT have more complicated chemical structures that are more difficult to copy. Two, because some DMT are biologics, meaning they are made from or by living organisms and cannot be chemically copied. However, biologics can be made to have a nearly identical structure and function and therefore are called “biosimilars”.
The FDA sets high standards to assure that generics and biosimilars function the same way as the original brand-name products they copy. The USA has a long and strong safety track record using generic medications. Some of the safety information for biosimilars comes from Europe where they have been manufacturing biosimilars since 2006. Of the over 30 biosimilars approved in Europe, there have been no concerns about safety or how well they work to treat disease.
The Why
The purpose of generics and biosimilars is to lower the costs of drugs and make them more widely available. Generics and biosimilars cost less because they only have to show that they are the same as the brand-name drug in their structure and function. The companies do not have to conduct the large, expensive clinical trials that initially proved that drug is safe and effective. Instead, companies can focus on replicating the manufacturing and bringing the products to market at a lower cost.
Congress passed legislation in 1984 to encourage generic drug production and again in 2009 to promote biosimilar production. These acts balance the need to protect the investment of the innovator companies who produced the original brand name drugs with the need to lower drug costs. Glatiramer acetate, dimethyl fumarate, teriflunomide and fingolimod are examples of DMT that have FDA approved generic formulations. A biosimilar agent exists for rituximab, a medication sometimes used off-label for MS. Other biosimilars are likely to follow once patents expire on the brand-name drugs.
The When
The VA MS Centers of Excellence (MSCoE) see the promise of lower costs and better access to DMT by using generics and biosimilars. Yet we also understand that some have concerns about safety or how well they will work. The good news is that the FDA has some of the highest standards in the world for approval of generics and biosimilars.
The policy for most US hospitals, including the Veterans Health Administration, is to give out generic drugs when they are available. The VA Pharmacy Benefits Management Service (VA PBM) carefully reviews all medications, including generics and biosimilars, to make sure they are safe, effective, and high quality. Together with VA PBM, MSCoE supports the use of VA approved generic and biosimilar DMT for our Veterans with MS and related disorders.
Additional Information
- National MS Society: Generic and Biosimilar Medications
- US FDA: Approved Drug Products with Therapeutic Equivalence Evaluations
- US FDA: Biosimilars
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