Emergence of Biosimilar Shaping the U.S. Pharmaceuticals Landscape

Emergence of Biosimilar Shaping the U.S. Pharmaceuticals Landscape

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In the dynamic landscape of the U.S. pharmaceutical market, the rise of biosimilars is creating a seismic shift, offering alternative treatment options and transforming the competitive landscape. Currently, the U.S. market boasts 42 approved biosimilars anchored on 12 reference products. This is a notable development, with seven biosimilars gaining approval in 2022, and an additional two in 2023. This surge contrasts starkly with the previous two years, which witnessed only seven approvals, largely attributed to pandemic-induced delays.

The march of biosimilars continues to gather pace, gaining momentum since 2019. An impressive total of 27 biosimilars have infiltrated the market, representing over two-thirds of the approved biosimilars.

According to projections by BioIntel360, the United States biosimilar market is poised for remarkable growth. The market size is forecasted to achieve a robust Compound Annual Growth Rate (CAGR) of 23.7% between 2023 and 2027, with estimates reaching an impressive US$11 billion by 2027, up from US$4 billion in 2023.

In early 2023, the long-awaited launch of the inaugural biosimilar for Humira® (adalimumab) materialized under the name Amjevita™ (adalimumab-atto), signifying a pivotal moment in the biosimilar landscape.

On July 1, 2023, as five distinct biosimilars of adalimumab (Humira) made their debut, heralding a new era of therapeutic choices. This ensemble includes adalimumab-abdm (Cyltezo), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), adalimumab-adaz (Hyrimoz), and adalimumab-fkjp (Hulio). These newcomers join the ranks alongside adalimumab-atto (Amjevita), the pioneering adalimumab biosimilar that embarked on its journey on January 31, 2023.

In the pipeline, a multitude of biosimilar applications await FDA consideration. These applications extend to reference products that have not yet been matched with an approved biosimilar counterpart. Among these are Eylea® (aflibercept), Tysabri® (natalizumab), Actemra® (tocilizumab), Stelara® (ustekinumab), Novolog® (insulin aspart), Humulin® R (human insulin), and Prolia®/Xgeva® (denosumab).

As the year unfolds, the scene is set for a fresh surge in biosimilar rivalry, reshaping treatment landscapes and patient choices. This transformative phase is accompanied by notable developments:

  • Breakthrough for Sandoz's Natalizumab Biosimilar: Sandoz secured FDA approval for natalizumab-sztn (Tyruko), a groundbreaking injectable treatment. This achievement marks a significant milestone as the first biosimilar version of the approved formulation of natalizumab (Tysabri; Biogen). Targeted at addressing relapsing forms of multiple sclerosis (MS) in adults, this biosimilar encompasses clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
  • CVS Health and pharmaceutical frontrunner Sandoz has forged a strategic alliance with a momentous objective: the creation of a near-identical iteration of the highly sought-after arthritis treatment Humira.
  • In a bid to fortify its foothold in the burgeoning biosimilar sector, CVS Health's strategic collaboration aligns seamlessly with its overarching goal. Industry experts predict that the biosimilar market is on track to expand significantly, reaching a doubled numerical value in the billions over the next six years.

BioIntel360 suggests that as biosimilar continue to reshape the healthcare landscape, patients and healthcare providers are poised to experience a transformative wave of choices, fostering a vibrant ecosystem of innovative alternatives.


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