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Number of new biosimilars for rare blood disorders approved in 2024
5
Resolution / Starting Odds
No new approvals • 25%
1 new approval • 25%
2 new approvals • 25%
3 or more new approvals • 25%
FDA official announcements or healthcare regulatory updates
Story
FDA Approves Amgen's Interchangeable Biosimilar to AstraZeneca's Soliris on Tuesday
May 28, 2024, 10:30 PM
The U.S. Food and Drug Administration (FDA) has approved Amgen's Bkemv, the first interchangeable biosimilar to AstraZeneca's Soliris, a treatment for rare blood disorders. Bkemv is approved for treating paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. This approval, announced on Tuesday, marks a significant milestone in the availability of biosimilar treatments for rare diseases.
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Remains 9 • 25%
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13 to 15 • 25%
More than 15 • 25%
Zero • 25%
One • 25%
Two • 25%
Three or more • 25%
None • 25%
1 • 25%
2 • 25%
3 or more • 25%
None • 33%
One • 33%
Two or more • 34%
0-5 • 20%
6-10 • 20%
11-15 • 20%
16-20 • 20%
More than 20 • 20%
Breyanzi • 25%
Yescarta • 25%
Kymriah • 25%
Other • 25%
No additional indications • 25%
One additional indication • 25%
Two additional indications • 25%
Three or more additional indications • 25%