As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023. On May 23, 2023, Amgen filed a motion to intervene in the case “for
Big Molecule Watch
FDA Approves Celltrion’s YUFLYMA (adalimumab-aaty), a Biosimilar to HUMIRA
Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. As we previously reported, Celltrion entered into an agreement…
New Patents Listed in the Purple Book for Regeneron’s EYLEA
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24…
FDA Approves the Cyltezo Pen, an autoinjector option for Adalimumab
On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially approved in August 2017 as…
Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation
By Keith Zullow
We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product. Briefing for the PI motion was to be completed by July…
Amneal Launches FYLNETRA (pegfilgrastim-pbbk) in the United States
Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. According to the press release, FYLNETRA—Amneal’s third biosimilar launch in the United States since late last year—is used to treat neutropenia (low neutrophils, a type of white blood cell that fights infection) which is commonly experienced by…
Proposed USPTO Fee Changes Could Impact PGR and IPR Filing Strategies Used by Biosimilars
The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.” Additionally, the PTO is proposing to allow IPR and PGR petitions to exceed the current word limits (14,000 and 18,700,…
Amgen Files BPCIA Complaint Against Sandoz Regarding Denosumab
On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a denosumab biosimilar. According to Amgen, PROLIA is “prescribed to treat patients with a high risk of bone…
Biogen Seeks Preliminary Injunction in Natilizumab BPCIA Litigation – Hearing Scheduled for May 17
In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI (natalizumab). The parties completed their briefing on Biogen’s motion in April, and Judge Williams has scheduled a hearing for May 17 at…
Samsung Files IPR Petition on Regeneron’s Aflibercept Patent
Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals. According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration.
As we previously reported, Apotex had…