Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: March 9, 2026
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: March 9, 2026
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…
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…
As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Enbrel® (etanercept). Yesterday, Lupin and Nichi-Iko Pharmaceutical announced that they…
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…
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,…
Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates. Below are some highlights. On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in…
Today, in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar, New Jersey District Judge Claire C. Cecchi issued an order that trial will commence on September 11, 2018. (Trial had originally been slated to begin this month.) The Court also ordered the parties to…
The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published. The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid…
Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the press release, this is the first…