FDA Issues Draft Guidance Q&A on Biosimilar Interchangeability Submission Requirements

December 02, 2020

The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.

Investigators: Biosimilar Pegfilgrastim Has Advantages Over Wearable Injector
Celltrion Relies on Domestic Construction Amid the Pandemic
Biosimilar Legal Roundup: November 2020
Newly Created Viatris Joins the Biosimilars Forum

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.

Not So Different: A Trio of Experts on What Needs to Change to Boost Biosimilar Adoption

November 29, 2020

Podcast

We sat down with a trio of experts to discuss the factors currently impacting biosimilar adoption, what reforms are needed to improve it, and what stakeholders can do to help.

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.

Part 2: Jorge Garcia on Giving Pharmacists Latitude to Switch to Biosimilars

November 25, 2020

Video

Jorge Garcia, PharmD, MS, MHA, MBA, assistant vice president of the System Oncology Pharmacy Service Line at Baptist Health South Florida, discussed how Baptist Health increases biosimilar use and how innovator companies fight to avoid biosimilar competition.

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.

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.

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