It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...

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the FDA expanded the biosimilar category to include 90 additional molecules, meaning there are now more therapies that can serve as reference products for biosimilars. This is significant because ...

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 ...

Biosimilars and biobetters present a lucrative ... have to follow the principles and guidelines as applicable for new molecules. However, there is a potential to refer to publically available ...

At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from ...

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing RulesMEDIA RELEASEFY 2024 net sales[1] of USD 10.4 billion, up by 9%[2] in ...

In 2024, FDA broke its record for annual original Biologics License Application (BLA) approvals by authorizing 18 new biosimilars referencing eight different molecules: The U.S. biosimilars market ...

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