Rheumatology

Opinion: Boehringer Ingelheim May Win Regulatory Language Change Despite Weak Argument

December 12, 2020

Sarfaraz K. Niazi, PhD

Article

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

Celltrion's CT-P17 Gains CHMP Recommendation for EU Marketing

December 11, 2020

Tony Hagen

Article

The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate.

Shanghai Henlius Biotech Gains China's Approval for Adalimumab Biosimilar

December 9, 2020

Tony Hagen

Article

The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.

Newly Created Viatris Joins the Biosimilars Forum

November 30, 2020

Tony Hagen

Article

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach.

Alvotech Scientific Officer Describes Company's Global Biosimilars Strategy

November 25, 2020

Tony Hagen

Article

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

November 24, 2020

Skylar Jeremias

Article

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

Opinion: Embrace the Era of Next-Generation Biologics

November 21, 2020

Bincy P. Abraham, MD

Article

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them.

Alvotech Files for US and EU Approval of Adalimumab Biosimilar

November 20, 2020

Tony Hagen

Article

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.

High Patient Retention Observed for Multiple Etanercept Switches

November 16, 2020

Tony Hagen

Article

Investigators said their study is valuable because biosimilar switching is likely to increase for economic reasons.

IGBA Launches Global Biosimilars Week

November 16, 2020

Tony Hagen

Article

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

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