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…
This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals. A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribal sovereign immunity cannot be asserted in IPRs.” Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…
Today, the U.S. FDA released its Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products. In remarks delivered at…
Today, Amgen filed a complaint for patent infringement under the BPCIA against Hospira and its parent Pfizer concerning their proposed biosimilar of Neupogen® (filgrastim). According to the complaint, the parties engaged in the patent dance, during which the parties negotiated and ultimately agreed that, of the seven patents that Amgen…