In early March 2024, Tyler Patchen reported that the U.S. Food and Drug Administration (FDA) approved both intravenous and subcutaneous formulations of Tyenne (tocilizumab-aazg) for use in a variety of inflammatory and immune conditions. These include rheumatoid arthritis (RA), giant cell arteritis (GCA), and both polyarticular and systemic juvenile idiopathic arthritis (JIA).
The Need for a Biosimilar for RA, JIA, and GCA Treatment
Tyenne is a biosimilar of Actemra (tocilizumab), an immunosuppressive drug and interleukin-6 (IL-6) receptor antagonist. The European Medicines Agency (EMA) describes Tyenne as a monoclonal antibody that:
[prevents] interleukin 6 from attaching to its receptors [and] reduces the inflammation and other symptoms of these diseases.
This biosimilar offers an effective, easy-to-access, and affordable therapy for patients in need. Outside of the United States, Tyenne is available in multiple other countries; its drug developer is also planning on further advancing Tyenne access across the globe.
What is a Biosimilar?
As you read the news about Tyenne’s approval, you might find yourself wondering: what exactly is a “biosimilar”? Don’t worry; we’ve got the details below.
The FDA explains that:
A biosimilar is a biologic medication [that] is highly similar to a biologic medication already approved by the FDA–the original biologic (also called the reference product). Biosimilars also have no clinically meaningfully differences from the reference product [which] means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would from the reference product.
Wait, you might ask. If there are no clinically meaningfully differences, aren’t they just the same product? The FDA provides more insights, saying:
Because most biologics are made from living sources (sugars, proteins, living cells, tissues), it is normal for both biosimilars and original biologics to have minor differences between batches of the same medication. This means that biologics cannot be copied exactly, and that is why biosimilars are not identical to the original biologic.
Biosimilars can be used to treat a variety of conditions including chronic bowel diseases, chronic skin conditions. diabetes, macular degeneration, multiple sclerosis, arthritis, and certain types of cancers. In many cases, biosimilars may be a more affordable option than the therapy they are based on.
