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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

Teva and Samsung Bioepis Launch Biosimilar Epysqli 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

BioRationality: Commemorating the 15th Anniversary of the BPCIA

Early market entry, manufacturing efficiency, and market share are critical to biosimilar development success, while technical complexity and competition heavily impact returns, according to a study presenting a risk-adjusted net present value (NPV) analysis framework.

Risk-Adjusted NPV Framework for Biosimilars Shows Key Investment Drivers

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Fewer AEs With Humanized Antibody Treatments Favorable for Biosimilar Development 

Case Study Indicates IVIG May Counteract Adalimumab

Dexpramipexole Lowers Blood and Tissue Eosinophils Without Severe Adverse Reactions