On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate. As we previously reported, on May 8, 2019, a Federal…
Below are some highlights of recent news in biosimilar and follow-on biologic development: On June 14, Sandoz announced positive clinical study data regarding HYRIMOZ, its biosimilar of HUMIRA (adalimumab). According to Sandoz’s press release, data from a 48-week phase 3 clinical study demonstrated that switching from HUMIRA to HYRIMOZ provides…
On June 11, Representatives Hakeem Jeffries (D-New York) and Doug Collins (R-Georgia) introduced a bipartisan bill with the stated purpose of addressing the rising cost of prescription drugs. According to the press release, the “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019,” H.R. 3199, would “significantly limit[] the…
On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab). In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures. Pfizer also…
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…