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…
Earlier this month, ACON Investments, a Washington, DC-based international private equity investment firm, announced that affiliates of ACON Latin America Opportunities Fund IV, L.P., in partnership with Humus Capital Partners (HCP), a middle-market private equity firm based in Buenos Aires, have acquired a majority equity interest in Biosidus S.A. and Biosidus…
Earlier this month, Oncobiologics, Inc. announced that it entered into a Master Service Agreement with Sonnet BioTherapeutics, Inc. that engages Oncobiologics to provide Contract Development and Manufacturing (CDMO) services for up to four drug product candidates over the next three years. According to the press release, this is the first CDMO agreement…
Today, the district court entered a scheduling order in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim). The scheduling order is generally consistent with the joint proposed discovery plan that the parties submitted last week and sets deadlines through the end of expert…