Accord BioPharma announced the FDA approval of its first biosimilar, Hercessi® (trastuzumab-strf), marking also the 50th biosimilar approval by the FDA.
“The approval of Hercessi—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” said Chrys Kokino, U.S. president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”
Originally designated as HLX-02, it was developed by Accord’s manufacturing partner Shanghai Henlius. Accord has the exclusive rights to commercialize Hercessi in the US and Canada. Accord enters the market as the sixth approved trastuzumab biosimilar, initially available only in a 150-mg dose. Accord anticipates approval of the 420-mg dosage before the end of this year. Â
A Launch Schedule for Denosumab Biosimilars?
Sandoz has reached a patent settlement with Amgen, which will enable the latter to launch its two denosumab biosimilars by May 31, 2025. The agreement ended litigation that was initiated May 1, 2023—a fairly rapid resolution.
At this time, Sandoz is the only agent to receive FDA approval for denosumab biosimilars. Celltrion filed for FDA approval in January of this year. Although no BPCIA patent litigation has been publicly announced in this case, one suspects that Amgen has (or will) file a suit to potentially delay the launch of CT-P41. In that case, subsequent settlements (and launch dates) will be announced among the 7 or 8 prospective manufacturers.
However, the main US patent for denosumab is expected to expire in February 2025. This may render further patent litigation by Amgen, the reference drug maker, moot. It may also affect Sandoz’s launch date, perhaps allowing earlier marketing of Jubbonti® and Wyost®.
Boehringer Ingelheim Cyltezo® High-Concentration Form Approved
Boehringer Ingelheim received approval from the FDA on May 1 for its high-concentration formulation of Cyltezo, which is available in 40-mg doses for both its prefilled syringe and autoinjector. Boehringer joins 5 other biosimilar manufacturers with a high-dose formulation of adalimumab.
