On February 8, the Federal Circuit issued a stay of the permanent injunction granted against the sale of Sanofi and Regeneron’s Praluent® (alirocumab). The injunction was to have become effective on February 21, 2017, but as a result of the stay, the companies can continue marketing, selling and manufacturing Praluent® pending the appeal of the injunction order. Sanofi and Regeneron…
On February 9, 2017, Aurobindo Pharma Limited announced that it acquired four biosimilar products, including a biosimilar of Bevacizumab, from TL Biopharmaceutical AG. TL Biopharmaceutical is to supply developmental data for each acquired molecule and Aurobindo will be responsible for development, commercialization and marketing activities. Aurobindo expects to conduct clinical…
According to a press release from GE Healthcare, Arven Pharmaceuticals, a Turkish pharmaceutical company, has selected GE Healthcare’s FlexFactory platform to increase its manufacturing capacity. GE describes FlexFactory as a centrally automated, flexible biomanufacturing platform that is primarily comprised of single-use technologies, associated process hardware, and integrated control components for…
Coherus BioSciences, Inc. announced yesterday that it had commenced an underwritten public offering of common stock valued at $125 million. These shares are being offered directly by Coherus in conjunction with an expected grant of a 30-day option to the offering underwriters to purchase an additional $18.75 million in common…
We post frequently about IPRs here on the blog, because they are an efficient and relatively quick way to get a decision on validity of the patents that cover drugs, biologic or otherwise. In Merck & Cie v. Gnosis S.p.A., the Supreme Court denied certiorari after the Federal Circuit affirmed that the standard…
Last fall, we reported on Pfizer’s 30% price cut to Enbrel® (etanercept) to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines, which requires price reductions for off-patent branded biologic medicines for which biosimilars are available. Yesterday, the Irish Times published a follow-up article describing some of the market…
The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee for Medicinal Products for Human Use (CHMP) had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved…
On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to Amgen Executive Vice President and CFO David Meline, Amgen is operating under the assumption of “biosimilar competition against Neulasta…
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front: Pfizer recently reported in a press release announcing financial results for Q4 2016 that in December 2016 its subsidiary Hospira resubmitted its aBLA for Retacrit,…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies including infliximab or cA2 antibody, is invalid. On January 26, 2017, pursuant to a 30-day extension, Janssen filed its opening appeal brief, in which Janssen challenged the two district…