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Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product based on the actual amount of active ingredient in a dose rather than a proposed standard that compares dosages and routes of administration. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More
Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015. Read More
Biosimilars promise to remain center stage in 2015 after the industry spent much of 2014 squabbling over everything from naming to substitution and the exact requirements of the pathway. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
The FDA moved one step closer to clearing the first biosimilar in the U.S. after agency staff recommended approval of Sandoz’s chemotherapy side-effect drug Zarzio, a version of Amgen’s blockbuster Neupogen. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More
A UK financial watchdog slammed Celgene’s pancreatic cancer drug Abraxane as too expensive and recommended against the English government reimbursing the therapy. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More