FDA biosimilar approvals set for record-breaking year amid US pricing reforms
2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests.
The FDA approved 19 biosimilars last year, a sharp jump from the five greenlit by the agency in 2023. GlobalData's Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate.
A total of 18 biologics will lose patent protection in 2025, up from 14 in 2024. This includes blockbuster products such as Amgen's Prolia (denosumab) and Roche's Perjeta (pertuzumab).
GlobalData, the parent company of Pharmaceutical Technology, states that projections indicate that 2025 could surpass 2024's milestone trend.
Debutants in 2024 included Amgen's Wezlana (ustekinumab-auub), the first of six biosimilars to Johnson & Johnson's (J&J's) blockbuster autoimmune drug Stelara (ustekinumab). Stelara generated $10.9bn in 2023, making it one of the top-selling drugs to gain biosimilar competition last year.
There were also five new drugs referencing the ophthalmology drug Eylea (aflibercept) that gained FDA approval in 2024. Regeneron's Eylea saw sales of $5.89bn in sales in 2023 before rivals entered the market.
It was also a strong 2024 for drugmakers in the space. Sandoz reported that biosimilar sales grew 30%, contributing to the company's $10.4bn net sales. Samsung Bioepis, another biosimilar specialist, posted a record-breaking financial year in 2024, with sales and operating profit up by 51% and 112%, respectively.
The spike in approvals is set against a backdrop of governmental pushes to increase reference drug use. US President Donald Trump signed an executive order (EO) earlier this week that overhauled pharmaceutical pricing in the country. According to a Reuters article, pharma companies launched new US drugs at prices 35% higher in 2023, compared to those launched in 2022. Biosimilars and generics can be as much as 80% cheaper than branded alternatives.
Kathryn Kinch, senior pharma product manager at GlobalData, said: 'Increased approvals of biosimilars are likely to lower biologic prices, enhancing consumer demand and competition among drug companies, which will benefit contract manufacturing organisations through higher biosimilar volumes.'
As per a White House fact sheet, the EO 'increases the availability of generics and biosimilars'. Trump already pushed the FDA to expedite the development of lower-cost generic medicines and biosimilars in his first term as president.
Juliana Reed, executive director of the Biosimilars Forum, said: '[We are] pleased to see the Trump Administration announce meaningful action on several fronts, including reforms to make biosimilars available quickly and efficiently to all Americans who need them. The EO also accelerates approval of biosimilars through the FDA and requires transparency and fairness from middlemen who prioritise profits over patients.
'Safe, effective, and lower-cost biosimilars are the clear answer to America's skyrocketing prescription drug costs.'
"FDA biosimilar approvals set for record-breaking year amid US pricing reforms" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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