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. 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鈥檚 Prolia (denosumab) and Roche鈥檚 Perjeta (pertuzumab).
GlobalData, the parent company of 色界吧 Technology, states that projections indicate that 2025 could surpass 2024鈥檚 milestone trend.
Debutants in 2024 included Amgen鈥檚 Wezlana (ustekinumab-auub), the first of six biosimilars to Johnson & Johnson鈥檚 (J&J鈥檚) 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鈥檚 Eylea saw sales of $5.89bn in sales in 2023 before rivals entered the market.
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By GlobalDataIt was also a strong 2024 for drugmakers in the space. Sandoz reported that biosimilar sales grew 30%, contributing to the company鈥檚 $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: 鈥淚ncreased 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.鈥�
As per a White House fact sheet, the EO 鈥渋ncreases the availability of generics and biosimilars鈥�. 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: 鈥淸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.
鈥淪afe, effective, and lower-cost biosimilars are the clear answer to America鈥檚 skyrocketing prescription drug costs.鈥�
