The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation. The ‘784 patent is directed to certain N-terminally chemically modified protein compositions, as well as methods of treatment and manufacture. With dismissal…
About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the FDA to deny the petition. Today, the FDA posted an interim response on the docket (FDA-2015-P-4935)…
Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat HER-positive metastatic breast cancer patients. Pfizer also reported success in a separate study, REFLECTIONS B3271004, evaluating this biosimilar in early…
Coherus BioSciences, Inc., a global biosimilar company, is currently advancing three late-stage clinical products towards commercialization, namely CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar). In October, we reported that the FDA accepted Coherus’s aBLA for their pegfilgrastim biosimilar CHS-1701. Today, Coherus announced the acceptance of a Marketing…
Today Momenta Pharmaceuticals announced that M923, a biosimilar candidate of AbbVie’s Humira (adalimumab), met the primary endpoint in a Phase III trial of M923 for treatment of patients with moderate-to-severe chronic plaque psoriasis. According to Momenta, M923 also achieved all secondary endpoints and adverse events were comparable to Humira. As…
On November 15, 2016, the U.S. District Court for the District of Utah entered a stipulated order to stay Janssen’s pending lawsuit against HyClone Laboratories, which supplies cell culture media for manufacturing Celltrion’s Inflectra® (infliximab-dyyb) biosimilar product. Under the order, the Utah case will be stayed pending resolution of Janssen’s ongoing…
The following are some noteworthy news stories on the regulatory front: The FDA shared best practices for biosimilar development. The EMA okayed a combination of insulin glargine and lixisenatide for treatment of type-2 diabetes. If approved, which is usually a formality within around 60 days, the EU will be the first…
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…
Below is our Fall 2016 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 update (Summer 2016).
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari in Apotex v. Amgen. Previous coverage of Amgen’s opposition is available here. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference on December 9. Given…