- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
European Patent Office Delivers Setback to Alexion on Soliris Patents
Last week, Alexion disclosed in a filing to the US Securities and Exchange Commission that the European Patent Office did not grant Alexion its request for 2 patents on its brand-name eculizumab product, Soliris, a C5 complement inhibitor that treats rare and ultrarare diseases.
Last week, Alexion disclosed in a filing to the US Securities and Exchange Commission that the European Patent Office (EPO) did not grant Alexion its request for 2 patents on its brand-name eculizumab product, Soliris, a C5 complement inhibitor that treats rare and ultrarare diseases.
The Form 8-K, dated September 5, indicates that the office declined to grant patent application 3124029, which covers a pharmaceutical composition comprising an antibody or antibody fragment binding to C5 for use in treating a patient with paroxysmal nocturnal hemoglobinuria (PNH), and patent application 3167888, which relates to the composition of matter of eculizumab.
Alexion says that it is evaluating its options with respect to appealing the decision on these patents once it receives the office’s written decision.
The setback comes after the EPO revoked another patent for the drug, 2359834, following a multiparty opposition proceeding earlier this year. That patent had covered a pharmaceutical composition comprising a single-unit dosage form of an anti-C5 antibody or antibody fragment. Alexion signaled that it would appeal in that matter as well, and noted that, while an appeal is pending, the claims in the patent remain enforceable.
On the US front, Alexion faces challenges from Amgen, which recently saw the Patent Trial and Appeal Board institute 3 inter partes review proceedings for patents on eculizumab. The first is related to a method of treatment related to paroxysmal nocturnal hemoglobinuria by complement inhibition, the second concerns formulation, and the third is related to composition of matter.
Meanwhile, Amgen forges ahead with its development of its proposed biosimilar, ABP 959. The biosimilar developer is recruiting patients for a randomized, double-blind, phase 3 study of the proposed biosimilar in patients with PNH. Amgen expects to enroll 40 participants in this crossover assignment study that is expected to be completed in 2021.
Alexion also faces challenges from Samsung Bioepis, which has also begun enrolling patients in a phase 3 clinical trial of its proposed biosimilar—SB12—in PNH. Samsung Bioepis also expects its trial to be completed in 2021.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
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.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
