Goodwin’s Willy Jay is speaking on a panel this week at the Annual Meeting of the Association for Accessible Medicines, formerly known as the Generic Pharmaceutical Association, Access 2018. Mr. Jay’s panel focuses on issues relating to closing the legal loopholes blocking access to generics and biosimilars. AAM states that…
On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese pharmaceutical company. The clinical trial compared the safety and efficacy of YB113 to Amgen’s…
About one year after the U.S. withdrew from the Trans-Pacific Partnership, the Comprehensive Progressive Agreement Trans-Pacific Partnership (CPTPP) is to be signed in March by the remaining countries (with ratification expected in 2019). The remaining eleven countries include: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and…
The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…
A paper published in the Generics and Biosimilars Initiative Journal reports on “an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy.” The paper, which was based on studies funded by the Italian Ministry of Health,…
The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the…
As we previously reported, on September 20, 2017, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product. On November 28, 2017, J&J filed…
Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, the Defendants moved for summary judgment of invalidity of the sole patent-in-suit, the ‘487 patent, on the ground that the patent’s claims are indefinite. According to Defendants’ brief,…
The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding…
Last week, Johnson & Johnson held its earnings call for the fourth quarter of 2017. During the call, company representatives discussed an 8% decline in U.S. sales for Remicade as Johnson & Johnson “continued to compete in the phase of biosimilar entries.” As we previously reported, there are two biosimilars…