An FDA-approved biosimilar is a biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing FDA-licensed ...

Similarly, the company gave no definitive schedule for the U.S. rollout of Tyruko and Enzeevu. "This lack of a precise timing along with concerns related to tariffs should keep investors at bay for ...

Similarly, the company gave no definitive schedule for the U.S. rollout of Tyruko and Enzeevu. "This lack of a precise timing along with concerns related to tariffs should keep investors at bay ...

Enzeevu/Afqlir (aflibercept) launch in Europe in Q4 2025 3. Tyruko (natalizumab) launch in the U.S. by the end of the year, pending FDA approval of JCV assay CEO Richard Saynor emphasized three key ...

In 2024, the FDA approved biosimilar versions of Eylea, including the brand names Ahzantive, Enzeevu, Pavblu, Opuviz, and Yesafili. Anti-VEGF Treatments in the Pipeline In addition to injections, ...

Agreement offers rights to commercialize proposed biosimilar of Yervoy®* for treatment of variety of cancer types, targeting net reference medicine sales of USD 2.5 billion[1]Henlius to develop ...

In addition, there are now 5 aflibercept biosimilars approved in the US, 3 of which have been granted the interchangeability designation: Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis ...

The biosimilars Tyruko, Pyzchiva, Wyost, and Jubbonti are expected to hit the U.S. market in 2025, while Enzeevu is slated for a European launch in the fourth quarter of the year. Sandoz is confident ...