Legal

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

Article

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

Article

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

Article

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

Article

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.

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

March 17th 2024

By Skylar Jeremias

Podcast

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo

March 6th 2024

By Skylar Jeremias

Article

Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.

Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad

February 21st 2024

By Skylar Jeremias

Article

The US Department of Veterans Affairs (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.

Patient With MS Sues J&J Over ERISA Violation

February 14th 2024

By Skylar Jeremias

Article

After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the Employee Retirement Income Security Act of 1974 (ERISA).

Navigating the Biosimilar Patent Landscape With Ha Kung Wong

February 11th 2024

By Cameron Santoro

Video

In an interview with Ha Kung Wong, JD, he addresses the patent legal system biosimilars are required to undergo and how this helps resolve patent disputes early in the development process.