China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.
China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.
The first study, a randomized, double-blind, parallel, positive-controlled, single-dose study, assessed the pharmacokinetics (PK), safety, tolerability, and immunogenicity of the biosimilar versus the reference drug in 181 patients with CD20-positive B-cell lymphoma. Innovent and Lilly say that the PK study met its primary end point, area under the concentration—time curve from time zero to infinity, of the biosimilar versus the reference over a time frame of 91 days.
The second study was a multicenter, randomized, double-blind, parallel, positive-controlled phase 3 trial that enrolled 420 patients with diffuse large B-cell lymphoma who received either the biosimilar or the reference drug in combination with standard chemotherapy for 6 cycles as first-line treatment for newly diagnosed disease. The drug makers indicated that the trial met its primary end point of overall response rate over a time frame of 18 weeks.
“Malignant lymphoma is one of the top 10 malignancies in China, and incidences thereof are still rising and
pose
a heavy economic burden for the vast majority of patients. Anti-CD20 monoclonal antibodies are effective treatments for lymphoma. However, currently there is only 1 approved biosimilar in China,” said Michael Yu, founder, chairman, and chief executive officer of Innovent, in a statement announcing the topline results. “The results of clinical studies of IBI301, a potential biosimilar of rituximab, are encouraging. We hope that the launch of IBI301 in the China market will improve its affordability, so more patients with lymphoma can benefit from the drug,” he added.
Wang Li, senior vice president of Lilly China and head of Lilly China drug development and medical affairs, added, “The results of these studies have significant clinical value and show the outstanding research and development capabilities of Innovent. We hope that IBI301 can be approved soon in order to offer an affordable treatment option for lymphoma patients in China.”
These positive results are the latest in a line of biosimilar news for Innovent; the company in late 2018 applied for Chinese regulatory approval of its proposed adalimumab biosimilar, which was studied in a phase 3 clinical trial in patients with ankylosing spondylitis. Also in 2018, the company filed for Chinese approval of its proposed bevacizumab biosimilar, which was studied in patients with advanced nonsquamous non—small-cell lung cancer.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
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.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.