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…
As we previously reported, on April 24, 2018, Biogen announced that it had plans to exercise an option to acquire up to a 49.9% equity stake in Samsung Bioepis, its joint venture with Samsung BioLogics. Yesterday, Biogen announced that it has exercised its option to purchase additional shares of Samsung…
As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for summary judgment pending before Judge Wolf in the District of Massachusetts. Both parties have filed competing summary judgment motions directed to damages issues. Additionally, Defendants have filed a motion…
Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept). Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…
The FDA’s Center for Biologics Evaluation and Research (CBER) is launching a new program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs). INTERACT meetings will replace pre-pre-IND meetings, but not formal product-specific meetings, such as pre-IND or pre-BLA meetings. According to the announcement, sponsors will be able to…
On Friday, in WesternGeco LLC v. ION Geophysical Corp., the Supreme Court held 7-2 that patentees may recover lost foreign profits based on infringement under 35 U.S.C. § 271(f)(2), reversing the Federal Circuit. Justice Thomas, writing for the majority, concluded that even if the presumption against extraterritoriality applied, the award of…