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Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures.

In the U.S., the first biosimilar was launched in September 2015. As I write this, there are 38 FDA-approved biosimilars; 22 of them are commercially available. These 22 products compete in nine molecule classes across oncology, rheumatology, diabetes care, and now ophthalmology. According to the most recent “U.S. Generic & Biosimilar Medicines Savings Report” from the Association for Accessible Medicines, biosimilar savings in the U.S. were $7.9 billion in 2020 (three times higher than savings from 2019) and have the potential to increase to $133 billion by 2025.


Biosimilars for oncology have been among the most often-cited success stories. Nearly 80% of biosimilars launched in the U.S. have indications for oncology, and market adoption has been strong across both therapeutic and supportive products. Biosimilars for Avastin (non-proprietary name bevacizumab, used to treat various types of cancer) are nearing 80% market share; biosimilars for Rituxan (non-proprietary name rituximab, used to treat certain types of cancer and autoimmune diseases) surpassed 70% market share; and biosimilars for Neupogen (non-proprietary name filgrastim, often used in combination with many cancer treatments to stimulate the growth of white blood cells to fight off infections) have started to stabilize in the low 90% share range.

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