“Because of patent settlements, patients will be able to access lower-cost biosimilar versions of Humira in 2023, approximately 14 years before some of the patents on Humira expire.”Ī total of six FDA-approved Humira biosimilars are now cleared for a 2023 release in the U.S. “Patent settlements remain a key tool to expedite patient access to generic and biosimilar medicines,” Karin Hessler, vice president and deputy general counsel for the Association for Accessible Medicines, told Healio Rheumatology. At the time, it was the last major legal standoff over Humira, capping a string of lawsuits resulting in eight drug makers settling with AbbVie - all of them agreeing to delay the launch of their Humira biosimilars until at least 2023. In May 2019, AbbVie and Boehringer Ingelheim announced a legal settlement that will allow the latter company to begin selling its own Humira biosimilar, Cyltezo (adalimumab-adbm) in the United States starting July 1, 2023, after paying royalties to AbbVie. “At that time, they may shift gears, stop marketing Humira and start marketing their JAK inhibitor and IL-23 inhibitors.” All Eyes on 2023 “AbbVie is doing the same thing with Humira, until they get their next JAK inhibitor and IL-23 drug marketed around the same time as these ancillary patents will run out,” he predicted. “What Janssen did with Remicade was protect it until they had their next agent available, which was Stelara, and now they are marketing Stelara.” “As you know, biosimilars in inflammatory bowel disease are here for infliximab, and they have been around, but I think you have to understand the context of how this evolved,” Hanauer told Healio Rheumatology. patents for Humira, some of which will not expire until 2037 - Hanauer predicted that they may instead simply fend off competition until they can develop a new, more exclusive drug to market. Rather than fight the release of biosimilars indefinitely through new patents for old drugs - a strategy that saw AbbVie apply for more than 250 U.S.
Hanauer, MD, Clifford Joseph Barborka professor of medicine at the Northwestern University Feinberg School of Medicine, the developers and patent holders of biosimilar reference products may have begun changing strategy. Since then, the FDA has approved five other adalimumab biosimilars, none of which are currently available, as they have, until recently, been tied up in the tale of ongoing patent litigation.Īccording to Stephen B. AbbVie has so far been successful in fending off the release of any adalimumab biosimilars since the FDA approved the first one, Amgen’s Amjevita (adalimumab-atto), in September 2016. This volley of dueling legal actions is merely the latest chapter in what has been a familiar story for AbbVie and its blockbuster TNF inhibitor, Humira. “Because of patent settlements, patients will be able to access lower-cost biosimilar versions of Humira in 2023, approximately 14 years before some of the patents on Humira expire,” Karin Hessler told Healio Rheumatology. Just 2 weeks prior, AbbVie had filed a lawsuit of its own against Alvotech - currently seeking FDA approval for its Humira (adalimumab) biosimilar AVT02 - accusing Alvotech of patent infringement related to that biosimilar application.
On May 11, Icelandic-based drug developer Alvotech filed a lawsuit against AbbVie seeking to undo what it alleges is a “minefield” of “invalid” patents surrounding what is arguably the pharma giant’s most prized possession: Humira. If you continue to have this issue please contact to Healio