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PTAB Will Review Key Patents on Brand-Name Eculizumab, Soliris
Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.
Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review (IPR) proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.
IPR proceedings are trials conducted by the PTAB that allow the board to review the patentability of 1 or more claims of a patent, and IPRs are instituted if there is a reasonable likelihood that the petitioner will prevail on at least 1 claim challenged. Decisions in instituted IPRs are typically issued within 1 year.
The first case, IPR2019-00739, is related to US Patent Number 9,725,504, which concerns a method of treatment related to paroxysmal nocturnal hemoglobinuria by complement inhibition. The second case, IPR2019-00740, concerns US Patent Number 9,718,880, which relates to formulation. Finally, case IPR2019-00741, is related to US Patent Number 9,732,149, which concerns composition of matter.
News of the IPR institutions comes just months after Amgen announced that its proposed eculizumab biosimilar, ABP 959, showed pharmacokinetic and pharmacodynamic equivalence to Soliris in a phase 1 study. The biosimilar also demonstrated similar safety and immunogenicity to its reference in the study.
Alexion has been attempting to “convert” patients currently receiving Soliris to its follow-up C5 complement inhibitor, Ultomiris, as Alexion’s chief executive officer Ludwig Hanston said earlier this year. Ultomiris offers less frequent administration than Soliris, but to date, Ultomiris carries 1 FDA-approved indication (PNH) to Soliris’ 4 (PNH, atypical hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder).
Alexion has also been highly reliant on Soliris for its revenue; last quarter, the drug brought in $980.8 million for the company, versus just $54.2 million for Ultomiris.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
