Regulatory

Poll: How Much Do You Know About Biosimilar Suffixes?

November 30, 2020

Article

Biosimilar suffixes were intended to help with pharmacovigilance, but they are not widely understood.

Henlius, Celltrion Group Report Product Development Advances

November 28, 2020

Tony Hagen

Article

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

EC Eyes Enhancements for a Post–COVID-19 Marketplace

November 27, 2020

Tony Hagen

Article

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

Samsung Bioepis CEO Discusses the Pandemic's Effect on Biosimilars

November 26, 2020

Tony Hagen

Article

Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.

Bio-Thera Solutions Files for EU Bevacizumab Approval

November 25, 2020

Tony Hagen

Article

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

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.

European Commission Approves Pfizer's Pegfilgrastim Biosimilar

November 23, 2020

Tony Hagen

Article

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

Survey: Providers, Admins Struggle to Appreciate Biosimilar Suffixes

November 20, 2020

Tony Hagen

Article

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

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.

Fed Expert Describes Improving Regulatory, Policy Structure for Biosimilars

November 19, 2020

Tony Hagen

Article

Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.

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