On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more
On April 7, 2025, Samsung Bioepis and Teva announced the launch of Epysqli® (eculizumab-aagh), a provisionally interchangeable biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), at a 30% discount to Soliris®’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
Welcome to Venable’s BiologicsHQ Monthly Injection – June 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
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
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
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
Affirming judgment of noninfringement of one patent and reversing judgment of infringement of another patent. All asserted claims required a particular process step, construed as defined by one example in the specification,...more