US states continue to form disparate views of how to deal with biosimilars as Delaware Governor Jack Markell (D) signed into law last week a bill that would require pharmacists to notify prescribers if a biosimilar is substituted for a biologic.
BioPharma-Reporter.com recently spoke with contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s...
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
Live insects observed during filling operations at a Greer Laboratories facility were one of a number of violations in the manufacture of its biological allergenic extracts cited in a US FDA warning letter.
As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
As Celltrion anticipates applying for US FDA approval for its Remsima biosimilar in the first half of 2014, the company this week filed suit in US District Court in Massachusetts against Janssen seeking to invalidate patents that would stop such a launch.
In direct opposition to a petition raised by GPhA (Generic Pharmaceutical Association) and Novartis, AbbVie, Genentech and Amgen are all looking for the US FDA to call for new non-proprietary names for biosimilars.
GSK’s Eperzan (albiglutide) has become the first approved drug to use the Veltis half-life extension technology and, according to Novozymes, may make it a strong competitor in the GLP-1 agonist market.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.