Development

Regulatory Policy May Not Stop Comparative Efficacy Trials

November 3, 2020

Tony Hagen

Article

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

Ten Reasons Why Biosimilar Candidates Should Not Be Tested for Clinical Efficacy

October 31, 2020

Sarfaraz K. Niazi, PhD

Article

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

SomaLogic Inks Proteomics Deal With FDA for Biomarker Development

October 30, 2020

Tony Hagen

Article

A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

Mvasi, Kanjinti Add Heft to Amgen's Third-Quarter Sales

October 29, 2020

Tony Hagen

Article

Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.

Alvotech Locks In $65 Million for Biosimilar Development

October 27, 2020

Tony Hagen

Article

With a sizeable round of fresh capital, Alvotech hopes to bring monoclonal antibodies and fusion proteins through the development pipeline.

Henlius Inks Global Bevacizumab Biosimilar Distribution Deal

October 21, 2020

Tony Hagen

Article

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

NeuClone's Ustekinimab Candidate Shines in Phase 1 Trial

October 20, 2020

Tony Hagen

Article

Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.

CT-P10 and Reference Rituximab Evaluated in Primary Sjögren Syndrome

October 20, 2020

Deana Ferreri, PhD

Article

Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.

ICER: Infliximab Is Highest in Cost-Effectiveness for UC

October 19, 2020

Skylar Jeremias

Article

Reviewers found that costs of reference infliximab and its biosimilars make it the most cost-effective therapy for ulcerative colitis (UC) among targeted immune modulators.

Revance Reports Positive Findings for Potential Botox Competitor

October 15, 2020

Tony Hagen

Article

DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.

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