December 13th 2020
By Tony Hagen
Health care policy expert Jane Halton, AO, PSM, has been picked for her extensive experience in governmental health affairs.
December 12th 2020
By Sarfaraz K. Niazi, PhD
Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.
December 11th 2020
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.
December 9th 2020
The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.
December 7th 2020
Anurag S. Rathore, PhD, wins a grant and the use of scientific instruments from Agilent to further his investigation.
December 4th 2020
By Skylar Jeremias
To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).
December 3rd 2020
By Deana Ferreri, PhD
A survey of 20 countries highlights the remaining regulatory challenges facing biosimilar adoption.
December 2nd 2020
The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.
November 30th 2020
Biosimilar suffixes were intended to help with pharmacovigilance, but they are not widely understood.
November 28th 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.
