Biosimilar approvals on the rise after a two-year slump — Amgen report

2022-10-14

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Amgen estimates that biosimilars resulted in $3.2 billion in savings last quarter alone, according to its latest trend report. And though the last two years saw a decline in overall approvals, the number of programs in development — and the uptake of available biosimilars — is on the rise. The team at Amgen took a deeper look at the US FDA’s 39 approved biosimilars — cheaper treatments that are just as safe and effective as their costly original biologics — and those still in development in its ninth annual trend report . Although only 22 of those products have launched on the market, Amgen approximates that they’ve created around $21 billion in savings over the last six years. “These new biosimilars have the potential to generate even more savings for the healthcare industry, which can then be deployed to newer, innovative treatments,” said Amgen, which has five biosimilars on the market. Despite just four biosimilars winning approval last year, Cardinal Health called it one of the “most eventful” in US history, adding in a recent report that momentum in the space is “stronger than ever.” Last year’s milestones included Viatris’ Semglee approval as the first interchangeable biosimilar, the first interchangeability designation for AbbVie’s blockbuster Humira, and Biogen’s OK for Byooviz, the first approved biosimilar in ophthalmology. “Prior to this year, it was predominantly oncology-focused medications, a little bit of rheumatology and then for only two months of 2021 was the insulin launch. Now we have two launches of biosimilars in the retina space, more products in oncology and then we have the first full year of the insulin,” Cardinal’s director of biosimilars, Jeff Baldetti, told Endpoints News on Friday. Six biosimilars have won approval so far this year, surpassing the four and three products approved in 2021 and 2020, respectively. That dip came after a record 2019, which brought 10 new approvals and 7 launches. Mizuho analyst Salim Syed noted in an email to investors on Thursday that the 2020-2021 decline was “possibly pandemic-related in part.” “Although there was an overall decline in the number of approvals during the 2020 to 2021 timeframe, the number of development programs that are participating in the FDA’s Biosimilar Development Program has continued to rise,” Amgen noted in its report. The biosimilars field has taken off since the first approval came through in 2015 for Zarxio, a version of Amgen’s white blood cell booster Neupogen. While the EU beat the US to its first biosimilar by several years, the bloc saw just 15 biosimilar approvals in the eight years after its first OK from 2006 to 2013, and the US has seen 39 approvals from 2015 to 2022. Progress in the US has picked up, experts say, despite pushback and patent litigation from pharma companies making top-dollar on their original biologics. Plus, uptake continues to climb, Amgen noted. Biosimilars launched in the last three years hold 75% of the market on average, according to the report. And the Inflation Reduction Act, signed into law back in August, will temporarily raise Medicare’s reimbursement for qualifying biosimilars, potentially making them more attractive to prescribe. “The temporary Medicare Part B payment increase for qualifying biosimilars that is now in effect will foster competition in the drug marketplace for conditions such as diabetes, cancer, and immune disorders, and will improve access to these life-saving medicines that help keep people with Medicare healthy,” CMS administrator Chiquita Brooks-LaSure said in a statement earlier this month. “I think that, in general, it’s going to be the beginning of an exciting year for biosimilars,” Baldetti said. “Probably the beginning of probably two years that [are] going to be quite a remarkable change as we see the evolution of a much more robust biosimilar market in the retail space.”

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