Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
A Conversation with Phil Hamzik
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
From Academia to the Marketplace: The Ins and Outs of University Spinout Licenses with Dan O’Korn
Wolf Greenfield Attorneys Preview What’s Ahead in 2024
5 Key Takeaways | Hot Topics in Biopharma
Business Better Podcast Episode: Accelerating Life Sciences: How Accelerators and Education Are Joining Forces to Catapult the Life Sciences Industry
Is Your Life Sciences Patent Enabled? The U.S. Supreme Court Is Considering That Question
Webinar: Orange Book listing sheets under the microscope
Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Enforcing IP in a Pandemic: Considerations, Risks, Strategies
[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
IP(DC) Podcast: Patent Battles – New Patent Initiatives on the Hill & Notable CAFC/SCOTUS Decisions
Patent law in Europe: What pharmaceutical companies need to know
A data-driven era: Why digital tools are critical to life sciences players
IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates....more
On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more
On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more
Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira®...more
Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more
During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more
Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more