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Generic and Biosimilar Medications

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Generic and biosimilar medications and multiple sclerosis

Generics and biosimilars are follow-on medications. A generic is a follow-on medication to a brand medication and a biosimilar is a follow-on medication to a biologic. They are determined by the U.S. Food and Drug Administration (FDA) to be bioequivalent to (the same as) or biosimilar to (functionally the same but not identical due to natural differences) the original medication.

Generics are bioequivalent to their brand name medication counterpart. Biosimilars are biosimilar to their biologic medication counterpart. Generics and biosimilars may offer additional treatment options and savings.

Generic medications

As explained by the FDA, a generic medication is created to be the same as a brand-name medication. It is equally safe and has the same dosage form, strength, quality and intended use. In other words, a generic medicine works in the same way and provides the same benefit as its brand-name version. You can take it as a substitute for the brand-name medication.

A generic medication can become available when a brand-name medication’s patent protections have ended. After a patent expires, manufacturers can apply for a license to manufacture and market generic versions of a medication.

Generic medications are often prescribed to help manage MS symptoms and other conditions. However, there are only a few FDA-approved generic disease-modifying therapies (DMTs) at this time. Some MS medications that currently have generics include Copaxone (glatiramer acetate, Glatopa), Gilenya (fingolimod), Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide).

The MS therapy landscape is continuously evolving. It is likely that more generic DMTs will become available to treat MS.

The Society’s Position on Generics

The Society’s Position on Generics

The Society advocates to increase access to personalized, affordable and high-quality healthcare for those affected by MS. This is reflected in our mission statement: We will cure MS while empowering people affected by MS to live their best lives. Generic medications approved by the FDA are safe and effective. The growth of the generic medication market for DMTs can increase access to affordable medicines, improve adherence and help contain healthcare costs.

The Society:

  • Supports empowering people with MS to participate in shared decision-making with their healthcare provider
  • Supports clear communication, education and awareness efforts to enhance utilization of generic DMTs
  • Supports detailed notification and tracking by pharmacists, providers and people with MS when generic DMTs are administered and used
  • Supports incentivizing the use of generics through the creation of sustainable generic DMT pricing policies, implementation of transparent insurance coverage guidelines and reimagining specialty formulary tiers
  • Supports a healthcare ecosystem where everyone collaborates on strategies leading to early and ongoing treatment

Reporting side effects

To report a side effect related to a medication, please use MedWatch, the FDA’s medical product safety reporting program.

Questions?

If you are a person living with MS or a carepartner for someone living with MS, connect with an MS Navigator Monday through Friday, 9:00am to 5:00pm ET at 800-344-4867. If you are a provider and have questions about biosimilars, email HealthProf_info@nmss.org. Additionally, you can reach out directly to the FDA at druginfo@fda.hhs.gov.

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Biologics and biosimilar medications

Biological medications (biologics) are made from living sources (such as animal cells, plant cells, bacteria or yeast) through a complex biotechnological process rather than a chemical manufacturing process. The term for an equivalent medication of a biologic is “biosimilar” or “follow-on biologic.” Biosimilars are also made from living sources. 

Biosimilars, like the originator biologics, will have natural differences even from batch to batch because they are made from living sources. These slight variations must fall within acceptable, predefined limits in order to ensure these variations do not result in any clinically meaningful differences and receive FDA approval. They are as safe and effective as the original biologic.

The FDA approval process for biosimilar medications is different from the process for generics. Many of the medications currently used to manage the MS disease course are considered biologics. As new biosimilar treatments for MS become available, these follow-on medications may provide more affordable options for people affected by MS.
 
For more information, view an FAQ about generic, biologic and biosimilar medications.

The Society’s Position on Biosimilars

The Society’s Position on Biosimilars

The Society strives to increase access to personalized, affordable and high-quality healthcare for those affected by MS. This is reflected in our mission statement: We will cure MS while empowering people affected by MS to live their best lives. Biosimilar medications approved by the FDA are safe and effective. As biosimilars are emerging within the DMT market, this can lead to an increase in access to affordable medicines, improve adherence and help contain healthcare costs.

The Society:

  • Supports empowering people with MS to participate in shared decision-making with their provider
  • Supports the implementation of rigorous and efficient pathways towards regulatory approval of biosimilar DMTs to accelerate and enhance approvability
  • Supports improving communication, education and awareness efforts to enhance utilization of biosimilar DMTs
  • Supports detailed notification and tracking by all pharmacists, providers and people with MS when biosimilar DMTs are administered and used
  • Supports incentivizing the use of biosimilars through the creation of sustainable biosimilar DMT pricing policies, implementation of transparent insurance coverage guidelines and reimagining specialty formulary tiers
  • Supports a healthcare system where everyone collaborates on strategies leading to early and ongoing treatment

Incorporating biosimilar DMTs into healthcare

Each person has a role in a patient-centered approach to incorporating biosimilar DMTs into patient care. Below is an outline of key responsibilities.

People living with MS:

  • Review health plan options carefully
  • Use trusted resources, such as the FDA, when researching information
  • Track and share health changes, outcomes and treatment experiences with care team

Providers:

  • Educate people living with MS about biosimilars, including the FDA approval process and the safety and efficacy of biosimilars
  • Discuss barriers to starting a treatment and adherence with your patients
  • Consider initial treatment with a biosimilar if an option of the appropriate biologic treatment exists
  • Contribute to tracking and long-term pharmacovigilance data to better understand the implications associated with cross-switching among biosimilars
  • Stay up to date with ongoing research of follow-on products and best practices in prescribing biosimilars

Pharmacists:

  • Provide individualized education and support to people living with MS, including treatment option information, cost resources and resolution of coverage issues
  • Direct people living with MS to reputable educational resources about biosimilars (i.e., the FDA, the National MS Society)

Policymakers:

  • Remove access barriers to biosimilars for both providers and people living with MS
  • Ensure that people living with MS receive cost-sharing protections for biosimilars, including but not limited to the use of financial assistance

Health plans:

  • Provide advanced notification to both patient and providers before any formulary change
  • Share cost information in a transparent manner
  • Create formulary structures that result in out-of-pocket cost savings by people living with MS
  • Implement policies that discourage frequent switching (i.e., cross-multiple-switching) between biosimilars
  • Ensure policies do not require use of a reference product first before allowing access to the biosimilar for that reference product

Manufacturers:

  • Label products clearly, indicating whether a biosimilar is interchangeable with the reference biologic
  • State all indications for which a biosimilar is approved, specifying whether supporting clinical data for the indication are derived from studies of the biosimilar or the reference biologic
  • Offer financial assistance programs
  • Communicate clearly with the public and offer unbiased educational information

To report a side effect related to a medication, please use MedWatch, the FDA’s medical product safety reporting program.

If you are a person living with MS or carepartner to someone living with MS, connect with an MS Navigator Monday through Friday, 9:00 a.m. to 5:00 p.m. ET, at 800-344-4867. If you are a provider and have questions about biosimilars, email HealthProf_info@nmss.org. Additionally, you can reach out directly to the FDA at druginfo@fda.hhs.gov.

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