In August, the American College of Rheumatology released updated guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), the two types of axial spondyloarthritis. The new recommendations suggest that patients use TNF inhibitors (Humira, Cimzia and Enbrel) as first-line therapy, followed by IL-17 inhibitors (Cosentyx and Taltz)…
This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of…
On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to…
United Healthcare and OneOncology have added Amgen’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns), biosimilars to AVASTIN and HERCEPTIN respectively, as preferred products, according to literature released by those providers. United Healthcare released a bulletin indicating that, as of October 1, 2019, United Healthcare will update its preferred product language to reflect…
Dr. Reddy’s Laboratories, Ltd. announced the launch of VERSAVO (bevacizumab), a biosimilar of Roche’s AVASTIN, in India today. VERSAVO is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and…
As we previously reported, in IPR2016-01542, Apotex successfully challenged all 24 claims of Amgen’s U.S. Patent No. 8,952,138, directed to a protein refolding process. Apotex had filed its IPR petition in August 2016, while it was in the midst of BPCIA litigations in which Amgen was asserting the ’138 patent…
As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen has asserted that Mylan infringes two protein purification process patents: U.S. Patent Nos. 8,273,707 and 9,643,997. Early this month, the district court requested the parties’ positions with regard to the ’707…
Below are highlights of biosimilar development news from the past couple of weeks: On August 5, Revance Therapeutics indicated on its quarterly earnings call that it has continued to have discussions with its collaborator Mylan about their proposed biosimilar of BOTOX (onabotulinumtoxinA) since their initial advisory meeting with the FDA…
Today, in the Immunex v. Sandoz BPCIA litigation, a District of New Jersey judge held that U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product Enbrel®” and U.S. Patent No. 8,163,522, related to Enbrel®’s method of manufacture, are not invalid. As we previously reported,…
On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…