Treatments for MS: Generics and biosimilars explained

‘Generic’ and ‘biosimilar’ medicines are treatments which are either identical or very similar versions of the original medicine that they are based on. Generic medicines are identical to the original treatments they are based on, whilst biosimilar medications are treatments that are very close to the original but not identical.  

What is a generic version of a DMT? 

A generic version of a drug is an identical version of the original branded drug. Generic DMTs can be made if the drug has a simple structure.  They’re made using the same process and the same chemical ingredients as the original. With the generic version, you take the same dose, in the same way and with the same possible side effects. Because it has the same ingredients as the original drug, it’s just as safe and works just as well. To make sure this is the case, a generic version goes through trials before it becomes available.   

This means generic medications can be taken as a direct substitute for the original brand name drug. The efficacy and safety of a generic drug should be exactly the same as the original branded version. The main difference will be that usually, a generic version of a DMT will be significantly cheaper than the brand name version. 

What is a biosimilar version of a DMT? 

A biosimilar is a version of a ‘biologic’ drug. ‘Biologic’ means these drugs are made using living organisms or cells taken from animals, humans or plants (such as proteins, genes or antibodies), and so they are much more complex in structure.  

Biosimilar medications are highly similar versions of original biologic drugs. While biosimilars are not exact copies, they are designed to be as close as possible in terms of safety, effectiveness, and quality. A biosimilar will have the same type of active ingredient as the original drug. Due to the complexity of biologics, creating an exact replica is challenging, but biosimilars undergo rigorous testing to ensure they perform similarly to the original product. They must also get approval from the relevant Regulatory Agency (such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). This means that a person living with MS should have the same clinical response to the biosimilar as they would to the original treatment. 

Why are these medicines available now? 

When a new medicine is developed, it is usually patented to exclude other companies from making or selling the medicine for a limited period. When this period ends, other companies can produce and sell their own versions of the same medicines. Generic and biosimilar treatments that are developed after the branded drug’s patent has ended are sometimes referred to as ‘follow-on’ treatments. 

Because the patents for several DMTs for MS have now come to an end, a growing number of treatments for MS have generic or biosimilar versions. 

How biosimilars and generics change the MS treatment landscape 

Biosimilars and generics generally increase access to medications. Increased competition in the market decreases costs to the healthcare system and, ultimately, drives down costs of treatments for individuals. It is important to note that the lower cost is not indicative of a less effective treatment.  

Biosimilar and generic alternatives provide more treatment options for patients and healthcare providers across the world. 

Biosimilar and generic treatments for MS 

Several DMTs for MS have generic or biosimilar versions. For example, dimethyl fumarate, originally sold under the brand name Tecfidera, has multiple generic versions now available. Similarly, natalizumab, known by the brand name Tysabri, has a biosimilar counterpart called Tyruko. When a company makes a generic or biosimilar version of a DMT, they might give it a new brand name, or they can add the company’s name before or after the drug’s actual name, for example, fingolimod-Teva. 

As the patent status of MS treatments changes, people with MS may be moved to a generic or biosimilar version of the DMT they were taking. This will be dependent on your location and the healthcare system in your country. Any change to the version of the DMT prescribed should be clearly communicated to you by your healthcare team. It is crucial that people with MS work closely with their healthcare team to ensure that they are following the correct treatment plan for them. 

Find an MS organisation near you to get information about MS treatments available in your country: Find MS support near you – MS International Federation 

Glossary 

• Generic medicine: An exact copy of a brand-name drug, identical in active ingredients, dosage, and administration.  

• Biosimilar medicine: A highly similar version of a biologic drug, matching in safety and effectiveness but not identical due to complex manufacturing processes.  

• Biologic drug: A medication derived from living organisms, often complex in structure and used to treat various diseases.  

• Disease-modifying therapy (DMT): A treatment aimed at altering the course of a disease, such as multiple sclerosis, to slow progression and reduce relapses.  

• Patent: A legal right granted to a company to exclusively produce and sell a new drug for a specified period.