In terms of approvals and launches, the biosimilars industry experienced a slowdown during the pandemic. But in the lab, there has been no such stagnation in the development of the copycats.
Even as the industry nears a critical moment in the U.S., the field appears to have picked up some significant momentum in the last few years, Amgen said in its "2022 Biosimilar Trends Report."
After biosimilars entered the scene in the U.S. in 2015, approvals and launches gained steam each year through 2019. In that year, 10 biosimilars won approvals and seven launched in the U.S., Amgen's report said. But in the pandemic years of 2020 and 2021, there were just a combined seven approvals and eight launches in the U.S.
By contrast, during this period, the number of biosimilars in development has steadily increased. A global snapshot from March of each of the last four years shows 77 programs in development in 2019, followed by 79 (2020), 90 (2021) and 96 (2022).
The most potentially impactful biosimilars are coming to the U.S. market in 2023, when copycats of AbbVie’s mega blockbuster Humira are set to debut. Amgen’s report shows how the introduction of Humira biosimilars in Europe three years ago sliced the branded med's share of sales there to 34%, while the top three biosimilars from Amgen, Sandoz and Samsung Bioepis now account for 20%, 19% and 15% of the market share, respectively.
Amgen points out that comparing biosimilar uptake in the U.S. and Europe is a dicey proposition because of their differing healthcare systems. To illustrate this, the report adds that there are significant differences in biosimilar uptake from country to country in Europe, ranging from Amgen’s 41% share in the U.K. with its Humira biosim Amgevita to its 19% share in France.
The report, in its ninth edition, also points to evidence of the growing commercial impact of biosimilars in the U.S. For therapeutic areas in which biosimilars launched before 2019, their average market share after three years was 39%. For biosimilars launched in the last three years, their average share is 75%.
Biosimilar drugs are providing some pricing relief, too. In the U.S., most biosimilar drugs are covered under the medical benefit, which covers medicines typically administered by a doctor. For biosimilars covered under this benefit, they have launched with a wholesale acquisition cost between 10% and 57% lower than their branded counterparts, the report says.
Similarly, savings by the U.S. healthcare system because of biosimilars has increased steadily and significantly in each quarter since they were introduced. Total savings to the system over the last six years has been $21 billion, Amgen estimates. In the second quarter of this year alone, the figure was $3.2 billion.