A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.
Shanghai Henlius Biotech reported positive phase 3 clinical study data for its bevacizumab biosimilar candidate (HLX04). The trial compared the biosimilar with reference bevacizumab (Avastin) in combination with the chemotherapy regimens Xelox and mFolfox6 as a first-line treatment for metastatic colorectal cancer (mCRC).
Investigators said HLX04 demonstrated efficacy, safety, and immunogenicity equivalence to Avastin. Potential oncology indications for HLX04, besides colorectal cancer, include advanced, metastatic, or recurrent non–small cell lung cancer.
The trial, HLX04-mCRC03, was a multicenter, randomized, double-blind, parallel controlled study that randomized patients 1:1 to the biosimilar candidate (n = 338) or reference product (n = 337) delivered intravenously (7.5 mg/kg every 3 weeks when combined with XELOX or 5 mg/kg every 2 weeks when combined with mFOLFOX6). The primary end point was progression-free survival (PFS) at week 36.
PFS was 46.4% in the HLX04 group and 50.7% for the reference cohort. Henlius said the group difference was –4.2% and fell within predefined equivalence margins, demonstrating biosimilarity. Investigators said there was no statistically significant difference between the biosimilar candidate and reference drugs in terms of overall survival, PFS, objective response rate, time to response, or duration of response. Safety and immunogenicity profiles also were equivalent.
“The results of the phase 3 study demonstrated the equivalence in efficacy between HLX04 and reference bevacizumab with similar safety and immunogenicity profiles as first-line treatment for mCRC patients. HLX04 will provide an alternative treatment option for cancer patients as a potential biosimilar candidate,” the company said.
Henlius also aims to obtain indications for ophthalmic diseases such as wet age-related macular degeneration and diabetic retinopathy.
Celltrion Group
Biosimilar developer Celltrion Group said it has completed enrollment of 327 patients for a coronavirus disease 2019 (COVID-19) drug candidate phase 2 clinical trial. If results are positive, the company aims to apply for emergency use authorization from the Korean Ministry of Food and Drug Safety.
In preclinical studies, the agent, CT-P59, demonstrated a 100-fold reduction in viral load of SARS-CoV-2, the virus that causes COVID-19, as well as a reduction in lung inflammation.
The phase 2, randomized, double-blind, controlled trial is evaluating CT-P59 in patients with mild and moderate symptoms of COVID-19 in 3 cohorts: placebo, low concentration dose, and high concentration dose. “Results from the trial are expected in the coming weeks,” said Sang Joon Lee, senior executive vice president of Celltrion.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
October 14th 2024During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.