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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
For the first time, a brand drugmaker has defeated a generics firm’s patent challenge through the U.S. Patent and Trademark Office’s internal review board process, which started in 2012. 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
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with good manufacturing practices. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
Sandoz’s bid to invalidate two patents protecting Amgen’s biologic rheumatoid arthritis therapy Enbrel was dealt a major blow last month after a federal appeals court affirmed that a patent challenge prior to submission of a biosimilar application is premature. Read More
Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. 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