Sandoz Clears a Patent Hurdle With Regeneron on Aflibercept Biosimilar
On September 9th, Sandoz announced that it had reached an agreement with the patent holder of the reference product Eylea, clearing its way for a launch towards the end of 2026.
The agreement with Regeneron halts all patent infringement proceedings against the biosimilar manufacturer. Regeneron had claimed Sandoz’s intended marketing of Enzeevu infringed on as many as 46 patents, some of which would not expire until 2040. In the face of this patent expiration claim, the ability to launch in the fourth quarter of 2026 seems a major victory.
Sandoz had received FDA approval for Enzeevu in August 2024, just before Amgen had begun marketing their aflibercept biosimilar Pavblu, in an at-risk launch. Three other aflibercept biosimilars have been approved (by Biocon, Formycon, and Samsung Bioepis) but await launch.
Organon and Henlius Obtain FDA Approval for Denosumab Biosimilars
In early September, the FDA gave Shanghai Henlius Biotech and Organon the nod to market their denosumab biosimilars Bildyos and Bilprevda (denosumab-nxx) for the reference products Prolia and Xgeva, respectively.
In a press release, Jon Martin, Organon’s US Commercial Lead, Biosimilars and Generic Medicine, stated, “Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women. This approval underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health.”
This approval marks Henlius’ second biosimilar approval in the US. “The FDA approvals of Bildyos and Bilprevda mark another set of Henlius’ self-developed and self-manufactured biosimilars approved in the United States, underscoring our commitment to scientific excellence and consistent product quality,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. Organon and Henlius will join a crowded field of denosumab biosimilars. Five other manufacturers have received FDA approval, lead by Sandoz’s Jubbonti and Wyost and Fresenius Kabi’s Conexxence and Bonmyntra, which have already launched.