Debunking DMT Myths: The Facts about Brand Name, Generics, Biologics, and Biosimilars

Sponsored by Sandoz

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19 Dec 2024 | ~5:26 Engagement Time

Authors

Roz Kalb , Psychologist

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The treatment landscape for multiple sclerosis (MS) continues to grow – with more types of medications to understand and more options to consider with your MS care provider. To help you navigate your treatment choices, we want to describe both the similarities and the differences between the available medications and clear up any misconceptions you may have about their relative effectiveness, safety, and cost. While having choices can sometimes feel confusing and overwhelming, the upside is that they offer you and your MS care provider the ability to tailor these choices to your needs, preferences, and lifestyle throughout your disease, all while attending to available insurance coverage. One size definitely doesn’t fit all. So, let’s clear up some misconceptions.

1. The Different Types of Multiple Sclerosis Medications Are Too Complicated to Understand

Actually, the differences are pretty straightforward. We currently have four types of medications for treating MS. Each of these medications must be evaluated and approved by the U.S. Food and Drug Administration (FDA) before they are marketed in this country.

  • Most brand-name medications are manufactured through chemical processing, which means that several chemicals are mixed in a way that makes them safe and effective for treating a specific condition – in this case, MS. Other brand-name medications are biologics.
  • A generic medication is a medication that is created to be the same as a brand name drug that is already on the market. The FDA requires that any generic medication be exactly the same as the brand name medication in quality, dosage, form, route of administration, safety profile, and performance.
  • Biologic medications (also called ‘products’) are manufactured differently. Rather than involving a chemical process, they are made from natural and living sources like animal and plant cells and microorganisms such as bacteria or yeast. Biologic medications brought to market by a pharmaceutical company to treat MS have brand names.
  • A Biosimilar is very close in structure and function to a biologic medication (known as the ‘reference product’) that is already on the market. The FDA requires that the biosimilar and its reference product have the same benefits and risks.

2. Brand Name Drugs Are the Best and Safest for Me

All of the medications approved by the FDA are safe and effective. Brand name medications are developed through a lengthy, complicated, and expensive process by a pharmaceutical company that hopes to bring it to market. Once the medication has passed muster in a series of clinical trials and been approved by the FDA, the company is able to manufacture and market the medication. At the same time, the company applies for patent protection for their new product so that no other company can make or sell the same medication for 20 years. These patents on new medications allow drug manufacturers to recoup their development costs.

Once a patent has expired – which has now occurred for several MS medications – a generic version of that medication can be made. According to FDA requirements, a proposed generic medication must demonstrate that, compared to the brand-name drug, it contains the same active ingredient, has the same strength, comes in the same form (e.g., pill, capsule, or liquid), and is administered in the same way (e.g., orally or by injection). In other words, the generic version must be bioequivalent to the brand-name medication, which means it behaves the same way in the human body.

The FDA’s rigorous review process for generic drugs ensures they have the same high quality, strength, and purity as their brand-name versions and are equally safe. You and your MS care provider will choose your medication based on your MS disease course, your insurance coverage, and your lifestyle and preferences.

3. Generic Medications and Biosimilar Medications Are the Same Thing.

Both generic and biosimilar medications are follow-on products. A generic medication is a follow-on to a brand name drug already on the market; a biosimilar is a follow-on to the reference biologic already on the market. That’s where the similarity ends. The generic is made of the same chemicals – with the same chemical processing – as the brand name drug. A biosimilar is very close in structure and function to its reference drug but not identical because they are both made from natural living sources that are inherently somewhat variable. The FDA’s role is to determine the equivalence of the generic medication to the brand name drug and of the biosimilar to its reference biologic drug. These follow-on products are not approved for use until the FDA is satisfied that equivalence has been achieved.

4. All MS Medications Are Equally Expensive

MS medications are expensive. However, the availability of generics and biosimilars has helped to reduce costs for manufacturers, consumers, and the healthcare system. The manufacturers of these follow-on products don’t have to complete the same lengthy and expensive clinical trials because the trials have already been done with the brand name and biologic medications. These savings can then be passed on to consumers, meaning you get the same safe and effective medications at a lower cost. On average, generics cost 79% less than brand-name medications, and biosimilars cost 15-35% less than their reference drugs. In addition, the availability of more options creates healthy competition in the marketplace, which helps to reduce healthcare system costs.

Insurers are much more likely to have the less expensive generics and biosimilars in their formularies, which means that your insurance may only cover these options. If, for any reason, you and your MS care provider choose a brand-name medication or biologic, your prescription costs will be significantly higher. However, most drug manufacturers offer financial assistance for their products.