This month the FDA published its Guidance for Industry titled “Considerations in Demonstrating Interchangeability With a Reference Product”. The guidance is “intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under…
Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …
On May 9, 2019, U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) announced that they had introduced the Affordable Prescriptions for Patients Act. According to the sponsors’ press release, the bill is designed to prevent “product hopping and patent thicketing within the Federal Trade Commission (FTC) Act.” In the…
Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo® (adalimumab-adbm). According to the press releases, AbbVie has granted BI a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States. All U.S. litigation pending between the parties…
On May 2, 2019 Coherus BioSciences, Inc. (“Coherus”) announced that it has settled the trade secret action brought by Amgen Inc. (“Amgen”) relating to Amgen’s Neulasta® and Coherus’ Udenyca® products. In March 2017, Amgen filed a complaint alleging a “massive conspiracy” by disloyal former Amgen employees in a “concerted effort…
The U.S. House of Representatives unanimously passed two bills yesterday, H.R. 1520 (Purple Book Continuity Act of 2019) and H.R. 1503 (Orange Book Transparency Act of 2019). The Purple Book Continuity Act of 2019 would require the Purple Book to publish lists of patents associated with approved biological products, but…
This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar. As we previously reported, in December 2017 the Northern California district court granted summary…
Taiwan-based EirGenix, Inc. and Sandoz recently announced that they have entered into an agreement, giving Sandoz an exclusive license to commercialize EirGenix’s proposed biosimilar version of Roche’s Herceptin (trastuzumab), which is now in in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast…
As previously reported, in December 2018, the District Court for the Northern District of Texas in Texas v. United States issued an order declaring that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, that the remaining provisions of the ACA are not severable from the mandate provision,…
As we have reported here and here, over the past couple of years Mylan has filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On April 2, 2019, the PTAB granted institution of two petitions (IPR2018-01675 and IPR2018-01676) challenging…