Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: April 16, 2024
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: April 16, 2024
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…
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…
Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab. In its decision, the Board explained that it was exercising its discretion to deny the petition in…
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights: On June 1, the Committee for Medicinal Products for Human Use…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and Celltrion v. Genentech (rituximab) As we previously reported, on January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District…
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…
Today, Pfizer announced that it received a Complete Response Letter (CRL) from the FDA in response to Pfizer’s application for its proposed biosimilar of Herceptin® (trastuzumab). According to Pfizer’s press release, the CRL “highlighted the need for additional technical information,” but the “requested information does not relate to safety or…
Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab). The CHMP opinion recommends…
Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).