March 31st 2021
By Tony Hagen
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a thumbs up for a subcutaneous (SC) infliximab biosimilar candidate from Celltrion.
Insulin is not a complex drug, but churning it out in massive quantities at high levels of purity is one of the main hurdles inhibiting biosimilar competition, panelists said.
March 30th 2021
Potential developers of orphan drug biosimilars face daunting challenges to get these drugs approved and onto market, said a panel of experts.
March 29th 2021
Regulators want built-in flexibility, and that benefits biosimilar developers, but there can be a price for this amount of latitude, panelists said.
March 26th 2021
A renowned expert on the life sciences industry in the United Kingdom provides an insightful look at Brexit and the importance for the pharmaceutical sector.
March 24th 2021
Biosimilars get short shrift in a proposed pricing model developed by the Drug Pricing Lab at Memorial Sloan Kettering (MSK), experts say.
mAbxience, which has been churning out AstraZeneca's COVID-19 vaccine, is ramping up its biosimilar capacity.
March 23rd 2021
By Deana Ferreri, PhD
Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.
March 22nd 2021
Peter Bach, MD, MAPP, and his Drug Pricing Lab at Memorial Sloan Kettering (MSK) argue profit caps will do better than the current biosimilar system.
March 19th 2021
Following lackluster experience with biosimilar marketing in the United States, Merck moves forward with spinoff plan.
