Legal

The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High

May 17th 2025

By Skylar Jeremias

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.

Eye on Pharma: Interchangeability, Private Labels, and Patent Settlements for Biosimilars

May 9th 2025

By Skylar Jeremias

Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors

March 11th 2025

By Ha Kung Wong, JD

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

January 9th 2025

By Cameron Santoro

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

Top 5 Most-Read Legal Articles of 2024

December 23rd 2024

By Skylar Jeremias

The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

November 21st 2024

By The Center for Biosimilars Staff

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Breaking Down Biosimilar Barriers: The Patent System

November 11th 2024

By Skylar Jeremias

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

October 15th 2024

By Skylar Jeremias

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

August 21st 2024

By Skylar Jeremias

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Patent Dance Insights: A Q&A on Reducing Legal Battles in the Biosimilar Landscape

August 18th 2024

By Cameron Santoro

In an interview, Ha Kung Wong, an intellectual property attorney, explained that the Biologics Price Competition and Innovation Act of 2009 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.