Regulatory

California's Anticompetitive Legislation Is Scrutinized at ACI

September 23rd 2020

By Tony Hagen

Panelists at American Conference Institute's (ACI) 2020 virtual summit discuss California's legislative attempts to improve competition in the drug industry.

Planchard, Pegram Review Evidence for Samsung Bioepis Biosimilars

September 22nd 2020

By Tony Hagen

Article

Biosimilars from Samsung Bioepis have demonstrated equivalency in clinical trial and real world settings, according to 2 prominent cancer specialists.

Alexion Gets CHMP Nod for New Ultomiris Formulation

September 22nd 2020

By Skylar Jeremias

Article

The Committee for Medicinal Products for Human Use (CHMP) recommendation for ravulizumab (Ultomiris) is for a dosage that involves a less rigorous schedule for administration.

Report: Lack of Biosimilar Competition Contributed to Billions in Lost Savings

September 21st 2020

By Skylar Jeremias

Article

The United States has missed out on almost $20 billion in savings as a result of not having a competitive biosimilar market, according to findings from the Pacific Research Institute.

Lotus Inks Deal With CKD to Distribute Darbepoetin Alpha Biosimilar

September 21st 2020

By Tony Hagen

Article

Lotus and CKD Pharmaceutical intend to be among the first to bring a darbepoetin alpha biosimilar to Southeast Asia.

UK Regulators Contend Biosimilar Efficacy Trials Are Redundant

September 18th 2020

By Deana Ferreri, PhD

Article

Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.

Celltrion's COVID-19 Antibody Treatment Moves Into Phase 2/3 Trial

September 18th 2020

By Skylar Jeremias

Article

Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.

PrestigePharma Reports Positive PK Data for Bevacizumab Candidate

September 17th 2020

By Tony Hagen

Article

Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.

ACP Calls for Biologics Marketplace Reforms

September 16th 2020

By Tony Hagen

Article

The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.

Merck's Etanercept Gains More Indications for Use in Canada

September 16th 2020

By Tony Hagen

Article

A broader range of indications in rheumatology combined with a Canadian push for biosimilar acceptance bodes well for Merck's Brenzys product.