Welcome, esteemed legal professionals, to the 20th issue review of the so-called ‘Blockbuster Biologics’. As per usual, we take a deep dive into the most recent happenings in the world of biologics and biosimilars, with a particular focus on patent litigation and post-grant challenges.
In the wake of the Biologics Price Competition and Innovation Act (BPCIA), we’ve seen a surge in the approval and launch of biosimilars. According to the most recent data, the tally stands at 41 approved biosimilars, with slightly more than half (22) having officially launched.
In the latest significant update, a settlement has been reached between biotech giants Janssen and Amgen. As per the accord, Amgen’s biosimilar to the over $4 billion-per-year seller, Stelara, will debut no later than the tick of the New Year on January 1, 2025. This event underscores the growing momentum of biosimilars and the influence they could bear on pricing and access in the biologics market.
For further insights into these developments, including a detailed breakdown of the implications of such settlements on the biologics market, please see the full publication here.
The evolving biosimilars landscape presents a series of complex legal challenges, and it’s essential for professionals in the field to keep abreast of the developments. Stay tuned for more updates as we continue to follow the progress of the BPCIA and its effects on the biologics and biosimilars market.