Humira may face competition from multiple generics next year. An octet of biologics may see competition this decade.
There are biosimilars on the market in the United States for nine different types and biosimilars have been approved by the FDA in two additional categories.
In July, the first ophthalmologic biosimilar, Byooviz (ranibizumab) began competing with the blockbuster originator Lucentis. The next category that is poised to see more biosimilars is immunology, where multiple biosimilars of Humira (adalimumab) are set to enter the U.S. market in 2023.
Humira competition is certain because FDA approvals have been issued and launch dates have been announced. Moreover, the makerters of the Humira biosimilar makers have signed agreements with AbbVie, Humira’s maker, that preclude the possibility of legal opposition.
Beyond 2023 and the Humira biosimilars are new categories of biosimilars whose launch timelines can be only be estimated based on pieces of information here and there. These launches are by no means certain and might drift well out into the future.
Cardinal Health in its 2022 biosimilars report said that more than 40 additional reference biologics are potential targets for biosimilar development. The company also made some projections about which biosimilars would come on the market by 2030.
Existing categories of biosimilars may also see new launches soon.
Biosimilars launched in the past three years have achieved an average market share of 74%, which is far better than the 3-year average of 38% measured in 2019, according to Amgen. This signifies growing acceptance of of biosimilars and potential for savings, although uptake in rheumatology has been sluggish and could be challenging in ophthalmology, according to Cardinal Health.
When it comes to patient access to important biologic medicines, much depends on the successful and timely launch of the biosimilars anticipated for the remainder of this decade.