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…
As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen and Mylan filed a joint status report in which the parties stipulated that Mylan does not infringe the asserted claims of US Patent 8,273,707. On August 21, 2019, after reviewing the…
We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of REMICADE (infliximab), as well as a related antitrust litigation filed by retailers Walgreen and Kroger Co. and direct and indirect purchasers of Remicade. The cases generally allege that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive…
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…
Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the journal Nature Biotechnology, examines the differences between the patent and drug approval legal and regulatory regimes and how…
As we previously reported, after Amgen obtained FDA-approval for MVASI (bevacizumab-awws), a biosimilar of Genentech’s AVASTIN, Amgen submitted—and the FDA approved—a number of supplements that revised, among other things, manufacturing and labeling information for the product. Genentech subsequently filed a motion in the district court, arguing that the FDA’s approval…
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…