FDA Approved 18 New Biosimilars This Year, Impacting 2024 Market Dynamics
Reprinted with AIS Health permission from the December 2024 issue of Radar on Specialty Pharmacy
In 2024, the FDA almost doubled its previous annual highest number of biosimilar approvals, besting 2019’s 10 by green-lighting an additional eight agents and bringing the total approved since 2015 to 63. Arguably the biggest story was that biosimilars of AbbVie Inc.’s best-selling Humira (adalimumab) finally began picking up market share. Speaking with AIS Health, a division of MMIT, industry experts reflect on the impact biosimilars had in 2024. (Editor’s note: These comments have been edited for length and clarity.)
Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group (PSG), an EPIC company: To date, there were 18 new biosimilars FDA approved in 2024, which includes biosimilars for five new brand reference products, most of which will not launch until sometime in 2025 or later. Most notable are the approvals of six biosimilars for Stelara [(ustekinumab) from Johnson & Johnson Innovative Medicine] expected to launch starting in January 2025. Stelara is a top drug for spend and trend in the inflammatory condition category for most payers, so biosimilars entering the market and creating competition to drive down price or offer cost savings is desirable by most payers. However, few coverage plan details for these new biosimilars have been released by several PBMs. Given the very slow uptake of Humira biosimilars and the continued strong market share of brand Humira, it is estimated the Humira brand still has over 70% of the market share. Ultimately, payers don’t know what to expect. Despite this uncertainty, the hope remains that the presence of Stelara biosimilars in the market will create the competition needed to result in lower costs and larger savings for payers.
Although the Humira brand still retains the bulk of market share, 2024 saw the first PBM, CVS Caremark, remove the Humira brand from the formulary, which seems to have resulted in a successful transition to Humira biosimilars for most of their existing Humira utilizers. The other large PBMs have announced plans to enhance Humira biosimilar coverage with white-labeling strategies similar to CVS starting in January 2025 and moving fully away from Humira brand by July 1, 2025.
Other notable approvals include five new biosimilars for Eylea [(aflibercept) from Regeneron Pharmaceuticals, Inc.], a drug billed on the medical benefit that is used for certain eye disorders. Some of these biosimilars have been blocked from entering the market until 2027 as a result of patent infringement litigation, but one, Pavblu [(aflibercept-ayyh) from Amgen Inc.], has launched at risk at approximately 10% below the brand Eylea list price. More litigation is expected in January 2025, so it is uncertain if that product will remain on the market pending outcomes.
Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth: During the first 11 months of 2024, the FDA approved 18 biosimilar products including biosimilars for Humira, Stelara, Prolia [(denosumab) from Amgen], Soliris, Eylea and Actemra [(tocilizumab) from Roche Group member Genentech USA, Inc.]. Some of these products were able to launch immediately, while others must wait to launch according to patent settlement agreement terms (e.g., Stelara biosimilars). In addition, the impact of biosimilars is also dependent on if the biosimilar is utilized more in the medical or pharmacy benefit. Typically, the pharmacy benefit provides greater opportunities for preferred product steerage than the medical benefit.
Biosimilar market share in the medical benefit continued to increase in 2024. As utilization of biosimilars increases, the average sales prices of both reference products and those biosimilar products decreases. On average, biosimilars are priced more than 40% lower than the brand biologic's price at the time of biosimilar launch. The availability of the lower cost biosimilars and their increased uptake are providing greater opportunities to lower the cost of drug spend in the medical benefit.
However, the total biosimilar market share remains low in the pharmacy benefit, especially for biologics like Humira. Market exclusively for the best-selling biologic Humira ended in January 2023, when the first biosimilar medication, adalimumab-atto (Amjevita [from Amgen]), became available. Since then, a total of 10 FDA-approved adalimumab biosimilars have launched in the market, some with pricing discounts 90% lower than Humira. The introduction of competition from lower-priced biosimilars provided an opportunity to switch from Humira to a biosimilar. During 2023 and early 2024, formulary coverages did not prioritize the lower cost treatment options. Beginning in the spring of 2024, more insurers began to favor adalimumab biosimilar utilization, and an increase in biosimilar utilization has been seen with the removal of branded Humira from payer coverages. The market share of adalimumab biosimilars has increased from 2% in early 2024 to 22% by October 2024. This is providing an opportunity for upfront savings for payers.
Mesfin Tegenu, R.Ph., CEO and chairman of RxParadigm, Inc.: Biosimilars had a profound impact in 2024, marked by the FDA's approval of 18 new biosimilars, a significant increase from just five in 2023. Among these approvals, four were the first biosimilars for their reference products, including Eylea, Prolia, Soliris [(eculizumab) from Alexion, AstraZeneca Rare Disease) and Xgeva [(denosumab) from Amgen]. The expanding pipeline of biosimilar approvals and launches is expected to drive further use and savings, with IQVIA projecting over $180 billion in savings over the next five years, a marked increase from the estimated $40 billion saved in the prior five years.
While adoption of Humira biosimilars started slowly, it gained momentum in April 2024 when CVS removed brand Humira from its major national formularies. This trend is expected to continue in 2025, with Express Scripts and Optum Rx announcing plans to remove Humira from their major formularies. Notable market shares for biosimilars included 86% for Herceptin [(trastuzumab) from Genentech] biosimilars, 89% for Avastin [(bevacizumab) from Genentech] biosimilars, 87% for Neupogen [(filgrastim) from Amgen] biosimilars and 56% for Lucentis [(ranibizumab) from Genentech] biosimilars, according to Samsung Bioepis. Looking ahead, the launch of Stelara and Eylea biosimilars in 2025 is expected to further accelerate the impact of biosimilars, with PBMs/payers likely implementing formulary changes more rapidly based on their experiences with Humira biosimilars. With Amgen set to launch the first Stelara biosimilar on Jan. 1, 2025, it will be interesting to see how these developments reshape the market.
By Angela Maas