By Kurt R. Karst – The once nascent biosimilars industry took off in 2015 with the first biosimilar approval (ZARXIO [filgrastim-sndz], which FDA licensed on March 6, 2015 under BLA 125553), myriad court decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) (see …
By Kurt R. Karst – Last week, the folks over at the Big Molecule Watch Blog broke the news that the U.S. District Court for Southern District of Florida (Judge James I. Cohn) ruled on a Motion for Preliminary Injunction (supplemented) filed by Amgen, Inc. and …
By James C. Shehan – In a citizen petition (Docket No. FDA-2015-P-4529) posted earlier this week, a group of fifteen institutional investors asked FDA to require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling” approach that the agency applied …
By James C. Shehan – On October 27th, the FTC submitted comments objecting to the FDA’s draft guidance on Nonproprietary Naming of Biological Products. In the comments and an accompanying press release, the FTC asserts that the proposal may reduce price competition in biologic drug markets, …
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
By Kurt R. Karst – One day in the future, reporting on biosimilar patent dance challenges lodged pursuant to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) will be considered passé. Such challenges will be as commonplace as Hatch-Waxman Paragraph IV challenges. Indeed, earlier …
By Kurt R. Karst – The Order handed down last week by the U.S. Court of Appeals for the Federal Circuit denying Amgen Inc.’s (“Amgen’s”) Emergency Motion For An Injunction Pending En Banc Consideration and Review and Sandoz Inc.’s (“Sandoz’s”) September 3, 2015 launch of the …
By James C. Shehan – On August 27, 2015, FDA published its much–anticipated views on the non-proprietary naming of biological products. Set forth in a proposed rule, a draft guidance, and a blog post, FDA proposes that a four letter suffix “devoid of meaning” be part …
By James C. Shehan – We’ve all been told that consistency is a virtue and some recent developments have AbbVie’s consistency on display while that company questions FDA’s biosimilar labeling morality, or at least decision-making. In a citizen petition supplement recently submitted to FDA, AbbVie renewed …
By Kurt R. Karst – It seems that hardly a week passes (and sometimes, hardly a day or two) without news of a new merger or acquisition in the pharmaceutical or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, …
By James C. Shehan – In the latest Biologics Price Competition and Innovation Act of 2009 ("BPCIA") patent dance development, Amgen filed a lawsuit alleging that Apotex’s biosimilar of Neulasta (pegfilgrastim) infringes two Amgen patents, one about to expire composition of matter patent and one process …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By James C. Shehan & Kurt R. Karst – On July 21, 2015, a fractured Federal Circuit issued its decision in the dispute between Amgen and Sandoz concerning various statutory issues under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). In a result that few …
By Kurt R. Karst – It was just a few weeks ago that we noted in a post concerning FDA’s recently finalized guidance document on “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” that the Agency removed from the 2012 draft version of the document …
By Kurt R. Karst – Here we are . . . on the eve of Oral Argument before the U.S. Court of Appeals for the Federal Circuit in a dispute over the applicability and correct interpretation of various provisions of the the Biologics Price Competition and …
