Kevin Esvelt warnings

Biopharmaceutical benchmarks 2022 | Nature Biotechnology 
 
 
 

 
 

 
 

 

 
 
 
 

 

 
 
 
 
 
 

 
 
 
 
 
 

 
 

 
 
 
 
 
 
 
 
 
 
 

 
 

 

 

 
 

 
 
 

 
 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 

 
 
 

 
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 Biopharmaceutical benchmarks 2022
 
 
 
 
 
 
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 Monoclonal antibodies as a group continue to lead biopharmaceuticals in numbers of approvals and sales, although COVID-19 vaccines shot to the top of the list of highest-grossing individual products.

 

 
 
 

 
 
 
 
 
 The past few years will forever be remembered as the years of a pandemic, the likes of which had not been seen for a century. And biopharmaceuticals took a starring role, with both COVID-19 vaccines and therapeutics dominating the news for the speed with which they were developed and their impact on global health. Nonetheless, regulatory agencies in both the United States and EU maintained the fast pace of prior years in moving products through their pipelines. This article is the latest survey of biopharmaceutical approvals, which we conduct every four years. The current survey period (January 2018–June 2022) witnessed the approval of 197 biopharmaceutical products (see Box 1 for definition) in the United States and/or EU, when counted by product trade name. Some products contain identical active ingredients or are sold under different trade names in the two regions; taking this into account, 180 distinct biopharmaceutical active ingredients entered the market.

 Box 1 Biopharmaceuticals defined

 Biopharmaceuticals (Table 1 ) are defined here as recombinant proteins, including recombinant antibodies, and nucleic acid- and genetically engineered cell-based products. They are listed in Table 1 consecutively from the most recent approval in each class, with registrations since 2018 indicated with boldface and withdrawals and discontinuations with italics. Eight categories are shown: recombinant clotting factors; recombinant thrombolytics, anticoagulants and other blood-related products; recombinant hormones; recombinant growth factors; recombinant interferons, interleukins and tumor necrosis factor; vaccines; monoclonal-antibody-based products; and other recombinant products. Where more than one drug in the same category was approved in

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