October 8th 2020
By Tony Hagen
Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.
October 7th 2020
The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.
October 6th 2020
By Skylar Jeremias
A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.
The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.
October 5th 2020
Researchers contend the "totality of evidence" for biosimilar approval may be sufficient to demonstrate interchangeability.
October 2nd 2020
Accord brought 2 biosimilars referencing blockbuster oncology products to the United Kingdom and amended its agreement with Shanghai Henlius Biotech.
October 1st 2020
By Deana Ferreri, PhD
Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia
September 30th 2020
September saw several biosimilar regulatory advances despite 2020 being a slow year for biosimilar approvals and launches.
The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.
September 26th 2020
An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.
