According to a Celltrion press release, this week investigators presented twelve-month data from a UK-wide, three-year prospective observational study showing comparable efficacy between CT-P13 (Celltrion’s biosimilar infliximab), reference infliximab (Johnson and Johnson’s Remicade), and adalimumab (AbbVie’s Humira). The press release reports that the Personalised Anti-TNF therapy in Crohn’s disease Study…
Express Scripts and Walgreens Boots Alliance announced this week that “they are expanding their group purchasing efforts to include the procurement of specialty brand drugs,” including biosimilars. According to Tim Wentworth, Express Scripts President and CEO, “[s]pecialty medications represent the most costly and complex drugs. By expanding our efforts with Walgreens Boots Alliance, we…
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, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written…
The United States District Court for the District of Massachusetts entered a scheduling order in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), for the remainder of discovery, pre-trial activities, and trial. The parties are ordered to reserve June 11, 2018 through June 29,…
Last week, the American College of Rheumatology (ACR) published a new white paper “encourag[ing] providers to incorporate [biosimilars] into the treatment plans of patients with rheumatic diseases where appropriate.” The paper, titled “The Science Behind Biosimilars — Entering a New Era of Biologic Therapy,” discusses the regulatory regime for biosimilars,…
After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the legislation would be to restrict “evergreening,” described as “the practice of extending…
The PTAB has denied institution of inter partes review of two Abbvie patents that relate to HUMIRA (adalimumab). On February 9, 2018, the PTAB denied Sandoz’s IPR2017-01824 on U.S. Patent No. 9,512,216, which is directed to a method of treating plaque psoriasis by subcutaneously administering a claimed regimen of adalimumab. On the same day, the PTAB…
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…