AbbVie raised its 2018 earnings guidance last week, based in part on increased sales of Humira (adalimumab). In its report on its second-quarter 2018 financial results, AbbVie noted a 10% increase in U.S. sales of Humira in the quarter, and stated during the earnings call that it expected U.S. sales…
Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…
Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement theory under the doctrine of equivalents. The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…
Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”). The Biosimilars Labeling Guidance provides recommendations for biosimilar product labeling, specifically for the proposed package insert, and is intended to help applicants in drafting labels for an aBLA. Some highlights…
Dr. Reddy’s Laboratories Ltd. announced today that it launched HERVYCTA (trastuzumab), a biosimilar of Roche’s HERCEPTIN, in India. According to the press release, HERVYCTA is indicated for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer), and is available in strengths of 150mg and…
As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States. Mylan stated at the time that it “anticipate[d] launching Fulphila in the coming weeks[.]” The next week, Mylan CEO Heather…
On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers. According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving…
Glenmark Pharmaceuticals announced positive results in a Phase 1 study comparing biosimilar GBR 310 to omalizumab, marketed as Xolair® by Genentech and Novartis. According to Glenmark, the study supports similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles. Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate…
We have previously reported on the Risk Evaluation and Mitigation Strategy (REMS) program, its effect on generic development, and the FDA’s guidance on how to prevent brands from using the REMS program to block generic entry. For an overview of REMS click here. On July 4, 2018, the Maine legislature enacted…
On July 20, 2018, Pfizer issued a press release reporting that the U.S. FDA has approved Nivestym™ (filgrastim-aafi), Pfizer’s proposed biosimilar of Neupogen®, for all eligible indications of the reference product. Pfizer states that “NIVESTYM is expected to be available in the U.S. at a significant discount to the current…