Development

Investigators Look to Cut Breast Cancer Recurrence With Posttrastuzumab Therapy

November 24, 2020

Tony Hagen

Article

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Celltrion to Break Ground on Massive New Biopharmaceutical Plant

November 19, 2020

Tony Hagen

Article

Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.

FDA Accepts Ranibizumab BLA From Samsung Bioepis and Biogen

November 18, 2020

Tony Hagen

Article

The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

Genentech Files to Block Marketing of Centus' Bevacizumab Biosimilar

November 17, 2020

Tony Hagen

Article

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

Supreme Court Hints Biosimilar Route Might Be Preserved

November 10, 2020

Tony Hagen

Article

The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.

OTBB Director Discusses FDA's Roadmap for Biosimilars

November 10, 2020

Tony Hagen

Article

Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.

Award: Samsung Bioepis Is Recognized for Advancing Biosimilars

November 5, 2020

Tony Hagen

Article

The company has multiple biosimilar products on the worldwide market and in development; in 2019, it gained World Health Organization precertification for a trastuzumab biosimilar (Ontruzant).

Getting Orphan Biosimilars to Market at a Lower Price

November 3, 2020

Tony Hagen

Article

Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but modifications to regulatory policy could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.

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.

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