by April Breyer Menon | Jan 26, 2025
On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). Avtozma® is indicated for the treatment of multiple diseases...
by April Breyer Menon | Jan 22, 2025
On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious. The claims are directed to ophthalmic formulations of a...
by April Breyer Menon | Jan 16, 2025
On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila. According to Optum’s formulary,...
by April Breyer Menon | Jan 14, 2025
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by April Breyer Menon | Jan 7, 2025
On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement allowing Steqeyma™...