Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a biosimilar version of Amgen’s Neupogen® (filgrastim). The first 2016 approval was Celltrion and Pfizer’s Inflectra®…
Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved 531 adult patients with moderate to severe plaque psoriasis in both switched and continuous treatment arms. Patients who switched…
Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. According to Amgen, Enbrel® is now “the first and only systemic therapy” for this indication, the approval of which was “based…
The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st. Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the “Framework Agreement”), which, starting August 1, 2016, set new pricing rules for medicines supplied to or reimbursed…
Yesterday, Catalent Pharma Solutions announced that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion of the expansion, Catalent will be able to provide biologics for late-stage clinical and commercial purposes. In addition, last…
Shire plc has returned development rights to two biosimilar candidates to Coherus BioSciences, Inc. and Momenta Pharmaceuticals, Inc., reportedly based on a strategic portfolio review following Shire’s June 2016 acquisition of Baxalta Incorporated. Coherus announced that it has “regained from Shire plc all development and commercial rights previously licensed for…
According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel® (etanercept). The biosimilar will be marketed in Canada under the brand Brenzys® as a treatment…
The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim)…
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). Considering the clinical evidence presented, PBAC recommended that there was “comparative safety and effectiveness of Brenzys and Enbrel.” Therefore, by substituting…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.