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…
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 United States Patent and Trademark Office (USPTO) issued a Notice of Proposed Rule Making (NPRM) outlining proposed increases in patent fees in a number of categories. In particular, America Invents Act (AIA) fees are subject to a 26% increase, substantially more than the 5% increase in…
As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States. In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending…
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…