On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here). In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including…
Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar available in Sri Lanka. The article states that the launch took place at the Cinnamon Grand Colombo in Sri Lanka, and…
On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval last week. Immunex’s complaint was filed in the District Court for the Central District of California and asserts patent infringement and seeks a declaratory judgment of…
The PTAB issued a Final Written Decision in IPR2016-00258, wherein Petitioner Green Cross Corp. challenged claims 1-3, 16, and 17 of Shire Human Genetic Therapies, Inc.’s U.S. Patent No. 9,051,556. Green Cross, which is developing a biobetter of Shire’s Elaprase (idursulfase) for Hunter syndrome, had argued that the challenged claims were…
JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL is pursuing as part of its strategic biologics alliance with Sanofi. According to the press…
We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an application for a variation to the marketing authorization to the EMA for XGEVA (denosumab). With these applications,…
Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab). BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. With the sBLA, Amgen seeks to add an indication for Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic…
In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular…
Today, AbbVie announced that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Fingernail psoriasis affects half of all psoriasis patients and HUMIRA is now the first-and-only biologic treatment with data on fingernail…
As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and policy, and the economics of the biopharmaceutical industry,” and “are concerned with the…