On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S....more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
In the latest development relating to patent eligibility of content-based identifier patents, the US Court of Appeals for the Federal Circuit affirmed decisions finding patent claims ineligible under 35 U.S.C. § 101....more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
On August 8, 2019, the Court of Queen’s Bench of Alberta dismissed Allergan’s application for judicial review of a decision by the Alberta Minister of Health (the Minister) to designate Allergan’s glaucoma treatment product...more
2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more
In an order issued on May 4, 2018, a Western District of Wisconsin Court addressed venue issues relating to subsidiaries of the same parent. Plaintiff Unity Opto Technology Co. (“Unity”) sued defendants Lowe’s Home Centers,...more
As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills. Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list....more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
In a series of recent decisions, the PTAB denied institution on a dozen petitions on related patents because of one problem it identified in the petitioner’s arguments. All of the petitioner’s proposed grounds challenged the...more