Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…
We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for this product. Stay tuned to Big…
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…
Yesterday, we reported that the House of Representatives was set to vote on a revised draft of the 21st Century Cures Act. The Act was passed by a 392 to 26 vote and will now head to the Senate for a vote next week. Stay tuned to Big Molecule Watch…
In June last year, we outlined the key exclusivity provisions in the 21st Century Cures Act. Then in July 2015, we reported that the House of Representatives passed a form of the Act by a vote of 344-77. Although the Senate has received and read it twice, the Act was…
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…