Biosimilars Poll: Which Way Will the Supreme Court Rule on the ACA?

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

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.

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.

The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?

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.

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.