There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey before Judge O’Hearn: Amgen Inc. et al. v. Celltrion, Inc., No. 1:24-cv-06497-CPO-EAP (D.N.J.), filed on May…
On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; Accord Healthcare, Inc.; and Intas Pharmaceuticals, Ltd., related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fifth BPCIA litigation regarding denosumab, following Amgen’s litigations…
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands. Celltrion also plans to launch STEQEYMA in Finland in mid-November, and in Ireland later in the month. STEQEYMA is the third ustekinumab…
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41…
As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh). A redacted version of the previously-sealed district court opinion was filed earlier this month. The…
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fourth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, and…
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would…
On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil’s bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year, with around 660,000 vials to be delivered through 2025. According to the announcement, HERZUMA is the most prescribed trastuzumab drug launched in Brazil and…
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions. STEQEYMA is a human IL-12 and IL-23 antagonist indicated for…
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs…