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…
Today, Genentech filed a complaint in the District of Delaware against Amgen concerning its aBLA for ABP 980, a proposed biosimilar of Herceptin® (trastuzumab). Genentech alleges infringement of 37 patents directed to a variety of different subject matters. According to the complaint, the parties engaged in the patent dance, during…
As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses. On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…
As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic. Today, FDA withdrew this draft guidance….
Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills. Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act directs pharmacists to dispense…
We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product. On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…