On February 21, 2018, Biocon reported that the FDA issued a Form 483 with six observations after the FDA completed a pre-approval inspection of the facility where Biocon plans to manufacture, in collaboration with Mylan, its follow-on insulin version of Lantus. Biocon indicated that it intends to respond to the FDA in…
JHL Biotech Inc. announced last week that it received approval from the Bulgarian Drug Agency for a Phase I clinical trial of its proposed bevacizumab (Avastin) biosimilar, JHL1149. The trial, set to begin in March 2018, will consist of a three-arm pharmacokinetic study in healthy volunteers. The data acquired from…
Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report. Among other things, the parties offered their competing proposals for discovery deadlines. The parties stated that they have been “engaged in the exchanges of information provided under the” BPCIA and that Pfizer provided its notice of…
The Association of Accessible Medicines (“AAM”) released a white paper on avoiding shortages and ensuring drug competition for patients in America. AAM is advocating for the uninterrupted availability of lower-cost generic and biosimilar medicines. In the paper, AAM asserts that by placing biosimilar medicines on a level competitive playing field with…
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…
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…
On Wednesday, July 12, 2017, Goodwin’s Elaine Blais will present as a featured speaker during the one-hour webinar, “Who Will ‘Dance’ Now? Biosimilars After Amgen v. Sandoz,” hosted by the IPO IP Chat Channel. Time: 2:00 PM – 3:00 PM ET To register as a participant, please click here.