Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe, Neulasta is indicated for the treatment of certain side effects associated with cytotoxic chemotherapy, including neutropenia. According to the two companies,…
We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Late last week, Merck announced that the FDA had accepted for review its New Drug Application…
As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61 U.S. patents (and five pending U.S. patent applications that have since been allowed), but that AbbVie has…
Check out our updated Inter Partes Review page with information about all of the IPRs filed on biologic products, including the patent challenged, product that may be covered by the patent, patent owner, challenger, IPR status, and links to the important documents. You can reach this page easily by clicking…
The District Court (D. Del., J. Andrews) has denied Hospira’s Motion to Dismiss in Amgen v. Hospira. As we’ve covered previously (see our posts here and here), Hospira moved to dismiss Count I of Amgen’s amended complaint, in which Amgen seeks both a declaratory judgment that Hospira’s alleged refusal to provide Amgen with 180-days’ post-licensure notice of…
AbbVie has filed a complaint against Amgen related to AbbVie’s Humira (adalimumab). The complaint asserts patent infringement and also seeks a declaratory judgment to compel Amgen to comply with the BPCIA’s notice of commercial marketing provision. Stay tuned to Big Molecule Watch for more details later today.
Yesterday, CVS announced that it would be dropping two brand-name biologic drugs from its standard formulary (list of medications CVS will cover): Amgen’s Neupogen® (filgrastim), and Sanofi’s Lantus® (insulin glargine). CVS will be replacing Neupogen® with Sandoz’s Zarxio® biosimilar product, and will replace Lantus® with Eli Lilly & Co.’s Basaglar® product,…
The Korea Herald reports that Archigen Biotech, a joint venture between AstraZeneca UK and Samsung BioLogics, has applied for FDA approval to begin Phase I clinical trials for its rituximab biosimilar, SAIT101. Archigen Biotech’s website states that clinical trials for SAIT101 are expected to begin globally in Q3 of 2016.
As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this past May, the district court for the District of Delaware (Judge Andrews) held a hearing to…
Today, AbbVie announced growth in Humira (adalimumab) sales to $4.15 billion worldwide in the second quarter, a 17.4% increase over the same quarter in 2015. On June 30th, AbbVie received FDA approval for a 10th indication for Humira: non-infectious intermediate, posterior and panuveitis in adults, which can severely impact vision. …