Earlier this week, JHL Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided it with positive scientific advice regarding JHL1101, its proposed biosimilar of MabThera® (rituximab). According to the press release, “the EMA confirmed that it agrees with JHL’s…
In a series of tweets on July 8, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that the FDA “will soon unveil a comprehensive Biosimilars Action Plan (BAP) that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase…
Goodwin attorneys and Big Molecule Watch editors Keith Zullow, Michael Cottler, and Joshua Whitehill were recently published on Bloomberg Law. Disputes often arise regarding what is required of a biosimilar applicant to comply with Subsection (l)(2)(A) of the BPCIA, a provision that kicks off the patent dance. Although this issue…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…
Last week, Genentech Inc. filed a complaint against Eli Lilly and Company (Lilly) in the United States District Court for the Southern District of California alleging infringement of U.S. Patent No. 10,011,654 (’654 patent) based on Eli Lilly’s commercial manufacture, use, sale, offer for sale and/or importation of Taltz® (ixekizumab) in…
Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands…
The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to…
As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed its opening Federal Circuit appeal brief in May, arguing that the district court made several errors in its…
Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710. According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…
United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.” According to the Senators, “biologics constitute a…