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).
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).
The American Society of Clinical Oncology (ASCO) recently issued a statement on use of biosimilars in oncology. According to ASCO, “[a]s many biosimilars come to market in the next several years, their use in oncology will play an important role in the future care of patients with cancer.” The statement offers “guidance…
As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of Amgen’s ‘878 patent — the only remaining patent at issue in the case — and damages. Amgen opposed both motions, and…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies. Johnson & Johnson reported that Remicade (infliximab) sales declined more than 1% in the U.S. and more than 8% worldwide year-over-year. During its earnings call, company executives explained that two-thirds of the decline in sales in Europe…
Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety,…
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017).
On July 31, Express Scripts identified new formulary exclusions that will go into effect on January 1, 2018. For example, Amgen’s rG-CSF product, NEUPOGEN, will be excluded in favor of Teva’s rG-CSF product, GRANIX, and Sandoz’s biosimilar, ZARXIO. Express Scripts has not explained, however, what the reimbursement level will be…
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit, i.e. (1) whether an injunction is available under state law; and (2) whether such a…
According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently marketed intravenous infliximab product (“CT-P13 IV”) in patients with rheumatoid arthritis. An earlier August 25, 2016 record on ClinicalTrials.gov…