On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product reportedly met all of the required regulatory standards. According to Merck, however, final FDA approval is subject to…
Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar reimbursement. A fact sheet prepared by CMS explains that the existing policy, finalized in 2016, provided that…
The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications….
On July 12, 2017, Amgen filed a Notice of Withdrawal of its Motion for Preliminary Injunction. As we previously reported, Amgen had filed an amended opening brief in support of its motion for preliminary injunction because of the Supreme Court’s decision in Sandoz v. Amgen. As we previously reported, Hospira…
In an earlier post, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission. Last week, Bioverativ, which markets the recombinant Factor IX product, Alprolix®, filed a Section 337 complaint against importation of CSL’s Factor IX product, Idelvion®, alongside a patent…
On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Amgen filed a revised brief in support of its PI motion. Amgen argued that Hospira’s…
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila (Pegfilgrastim), Ogivri (Trastuzumab), and Semglee (Insulin Glargine). The French National Agency for Medicines and Health Products Safety (ANSM), on…
On Wednesday, July 12, 2017, Goodwin’s Elaine Blais will present as a featured speaker during the one-hour webinar, “Who Will ‘Dance’ Now? Biosimilars After Amgen v. Sandoz,” hosted by the IPO IP Chat Channel. Time: 2:00 PM – 3:00 PM ET To register as a participant, please click here.
Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and Therapy. Noting that many European specialists had reported having only a basic knowledge of biosimilars, the authors sought to critically analyze…
On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior art. The Final Written Decisions were issued in IPR2016-00408 and IPR2016-00409, both filed by Boehringer Ingelheim. As we reported here, the ‘135 patent had previously been found unpatentable as…