AbbVie is about to face stiffer competition for its blockbuster rheumatoid arthritis drug Humira from a new biosimilar about to be launched in the US.
Celltrion Healthcare, a South Korean company, has introduced Yuflyma, a biosimilar version Humira, in the United States.
Yuflyma is being sold at a 5% discount compared to Humira, intensifying competition for the blockbuster rheumatoid arthritis drug.
According to reports, Celltrion is seeking an interchangeability designation from the US Food and Drug Administration for Yuflyma, a decision expected in the fourth quarter of 2024, which would mean the biosimilar can be substituted without the intervention of the healthcare professional who prescribed the reference product.
Celltrion joins other drugmakers like Boehringer Ingelheim, Sandoz, Organon, Fresenius, and Coherus BioSciences (NASDAQ:CHRS), which have also launched biosimilars this week.
A biosimilar is a type of biological medicine that is highly similar to an already approved reference biological product. Unlike generic versions of chemical-based drugs, which are exact copies of their reference products, biosimilars cannot be identical due to the complexity of biological molecules and the manufacturing process. However, they undergo a rigorous development and regulatory evaluation process to demonstrate that they have no clinically meaningful differences from the reference product.
Meanwhile, AbbVie has projected a 37% decline in Humira sales in 2023 due to increased competition, despite the drug having been the world's top-selling non-COVID prescription drug, generating a record $21.2 billion in sales in 2022.
Shares of AbbVie were up around 0.5% on Wednesday morning in New York.
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