Regulatory

Prestige Biopharma Plots Biosimilar Growth Strategy

January 20, 2021

Tony Hagen

Article

Biosimilars will be the cornerstone for a leap into biologics development and commercialization, according to the CEO of Prestige Biopharma. Also, Innovent Biologics reaches a marketing agreement.

Poll: Which of the following is true about insulin products and the BPCIA?

January 20, 2021

Article

Many patient advocates hope that expansion of the Biologics Price Competition and Innovation Act (BPCIA) will bring further competition to the insulin market—and lower prices.

IGBA, Celltrion, Others Mark Biosimilar Advances

January 17, 2021

Tony Hagen

Article

The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.

Opinion: Is the Ophthalmology Market Ready to Embrace Biosimilars?

January 16, 2021

Sonia T. Oskouei, PharmD, BCMAS, DPLA

Article

Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.

With New Policy, CMS Promises to Exit "Stone Age" of Health Information

January 15, 2021

Tony Hagen

Article

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests.

Charles Bennett, MD, PhD, Discusses the FDA’s Biosimilar Approval Timeline

January 13, 2021

Video

Charles Bennett, MD, PhD, a hematologist and oncologist and professor in the Clinical Pharmacy and Outcomes Sciences Department of the College of Pharmacy at the University of South Carolina, discussed the FDA’s pace of biosimilar approvals and the findings from his recent study.

Study: Machine Learning Could Optimize Biosimilar Therapy

January 12, 2021

Deana Ferreri, PhD

Article

Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy.

Hill Describes Supercharged Biologics Market in China

January 11, 2021

Tony Hagen

Article

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

Adalimumab Biosimilars Face Product Obsolescence Before Launch

January 6, 2021

Tony Hagen

Article

Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.

Alvotech Breaks Ground for Biosimilar Development Facility

January 3, 2021

Tony Hagen

Article

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

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