© 2020 MJH Life Sciences and Center for Biosimilars®. All rights reserved.
© 2020 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
December 02, 2020
The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.
December 01, 2020
November 30, 2020
Biosimilar suffixes were intended to help with pharmacovigilance, but they are not widely understood.
November 29, 2020
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.
November 28, 2020
A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.
November 27, 2020
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.
November 26, 2020
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.
November 25, 2020
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.
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.
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.
November 24, 2020
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.
GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.