Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction…
On June 8, 2019, Fresenius Kabi filed a petition for inter partes review challenging the validity of U.S. Patent No. 9,643,997, entitled “Capture purification processes for proteins expressed in a non-mammalian system.” The challenged claims in the patent, owned by Amgen Inc., relate to processes for purifying recombinant proteins expressed in a…
On June 5, 2019, Lannett Company, Inc. announced they would begin human clinical trials for an insulin glargine biosimilar. According to Lannett’s press release, “[i]nsulin glargine is a long-acting insulin used to regulate the blood sugar of adults with Type 2 Diabetes, as well as adults and pediatric patients with…
A recent analysis reveals that prescription drug prices continue to increase — even for drugs with FDA-approved therapeutic equivalents or biosimilar products. Dr. Nathan Wineinger evaluated the change in prescription drug prices over a 6-year period for the 49 top-selling brand-name medications in the United States. The price of 48…
We have previously reported on IPR2016-01542, in which Apotex challenged US Patent No. 8,952,138, directed to a protein refolding process. On February 15, 2018, the PTAB issued a final written decision finding claims 1-17 and 19-24 of the ’138 patent invalid. On March 16, 2018, Apotex requested a rehearing relating…
This month the FDA published its Guidance for Industry titled “Considerations in Demonstrating Interchangeability With a Reference Product”. The guidance is “intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under…
Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …
On May 9, 2019, U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) announced that they had introduced the Affordable Prescriptions for Patients Act. According to the sponsors’ press release, the bill is designed to prevent “product hopping and patent thicketing within the Federal Trade Commission (FTC) Act.” In the…
Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo® (adalimumab-adbm). According to the press releases, AbbVie has granted BI a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States. All U.S. litigation pending between the parties…
On May 2, 2019 Coherus BioSciences, Inc. (“Coherus”) announced that it has settled the trade secret action brought by Amgen Inc. (“Amgen”) relating to Amgen’s Neulasta® and Coherus’ Udenyca® products. In March 2017, Amgen filed a complaint alleging a “massive conspiracy” by disloyal former Amgen employees in a “concerted effort…