Key Facts Biosimilars are near-identical versions of biologic cancer drugs, available at lower costs. Germany saves hundreds of millions annually from just one biosimilar drug.

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. This presents a golden opportunity for Contract Manufacturing ...

The Food and Drug Administration (FDA) has designated Otulfi ® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara ® (ustekinumab). Otulfi is a human interleukin ...

The myth also may have been inspired by ceremonial helmets with horns found in Denmark in 1942, but those date to about 900 B.C. — over a thousand years before the Vikings.

Between 2020 and 2025, approximately 17 biologics with annual sales totaling $60 billion have lost or are losing exclusivity, and as of September 2023, the FDA had approved 43 biosimilars.

As of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules. Of the 73 approvals, 48 biosimilars (66%) have launched in the U.S. market.

At the core of the problem is the fact that India does not have a well thought-out regulatory law for biosimilars. It is crucial that the government gives this issue urgent attention because in a ...

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday. Like its reference ...

Demand for biosimilars is predicted to be expanding at a compound annual growth rate of nearly 18% from $9.4 billion in 2023 to $66.9 billion in 2028 (1). This strong growth reflects both higher ...

In 2024, when Amgen generated $33.4 billion in revenue, more than $2.2 billion came from sales of its biosimilars. It was a 16% increase from Amgen’s biosimilar sales in 2023 and the company ...