To say the PTO is gun-shy of media coverage and controversy would be an understatement, if its Sensitive Application Warning System (SAWS) is any indication.

In a 7-2 decision that will delay the launch of generics of Teva Pharmaceuticals USA Inc.'s Copaxone, the Supreme Court took issue Tuesday with the way the Federal Circuit struck down the remaining patent for the multiple sclerosis (MS) drug.

If numbers are anything to go by, 2014 was the year of the biologic. Nearly a fourth of the 41 novel drugs the FDA approved last year were biologics.

Nearly a year after the Federal Circuit set the record straight on calculating the length of patent extensions, the Patent and Trademark Office (PTO) is including that decision in a final rule that also could penalize those who request continued examinations (RCEs).

Despite some confusion over what's considered a clinically meaningful difference, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously Wednesday that Sandoz Inc.'s filgrastim biosimilar should be approved for all the indications of its reference drug, Amgen Inc.'s Neupogen.

The much-awaited guidance on interchangeability the FDA promised last year? It's now on the schedule for 2015, along with other biosimilar draft guidances on labeling, statistical approaches for evaluating analytical similarity data and implementation of the Biologic Price Competition and Innovation Act (BPCIA).

Seemingly confident in the level of similarity between Sandoz Inc.'s Zarxio and Amgen Inc.'s Neupogen, the FDA has one voting question for the Oncologic Drugs Advisory Committee (ODAC) that will weigh in Wednesday on what is likely to be the first U.S. biosimilar.

Expectations are riding high that 2015 will usher in stunning advancements to streamline the development and approval process of new therapies in the U.S.

With courts cracking down on pay-for-delay (PFD) settlements between brand drugmakers and generic competitors, the impact of those settlements may be on the decline.