Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k) pathway. Mylan stated that the FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9,…
Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA). Sandoz’s opening brief addressed: Whether notice of commercial marketing given before…
The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for the Southern District of Florida ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not…
According to BioPharma-reporter, Pfizer will close the Australian plant at which Pfizer manufactures API for HSP-130, a biosimilar version of Amgen’s Neulasta, by 2021. Pfizer will move production of the API to Croatia in an effort to consolidate manufacturing. HSP130 is currently in clinical trials. Stay tuned to the Big…
Sandoz filed its opening brief on Friday. Amicus briefs are due on February 17, and the full briefing schedule is available in our prior post. Big Molecule Watch will provide in depth analysis of the brief soon, so please check back for further updates on this case and other biosimilar-related litigation.
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…
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…