Drug maker Biocon has launched a biosimilar bevacizumab (referenced on Avastin) in India.
Indian drug maker Biocon announced on November 23 that it has launched a biosimilar bevacizumab (referenced on Avastin) in India. The biosimilar, which Biocon is marketing under the name Krabeva, will be used to treat patients with metastatic colorectal cancer as well as lung, kidney, cervical, ovarian, and colorectal cancer.
Arun Chandavarkar, PhD, CEO and joint managing director of Biocon, said of the launch, “With Kraveba, we intend to provide a high quality, world-class biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer. We believe Krabeva will be an important addition to our oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India.”
Regulatory approval for the therapy was granted on the basis of phase 3 clinical data from a study involving 146 patients with metastatic colorectal cancer. Currently, Biocon is undertaking a phase 3 trial in patients with non-small cell lung cancer at 100 sites in multiple countries, comparing its biosimilar with both US- and EU-licensed reference bevacizumab.
Notably, Biocon also announced that its bevacizumab includes a unique quality-assurance system, which it calls “QualCheck,” that will help to ensure the therapy’s quality up to the point of administration. The system comprises temperature-sensitive packaging, including thermo-chromic stickers that change color permanently if the product’s temperature rises to a level that could affect the safety, purity, or potency of the drug.
Announcement of the innovative packaging for Biocon’s bevacizumab comes at a time when many reference product sponsors and biosimilar developers are seeking ways to set their products apart from competition; after a study found that patients taking etanercept therapy preferred the auto-injector device provided with Merck’s biosimilar (Brenzys, Benpali), Amgen launched a reusable auto-injector device for its reference product (Enbrel). Amgen’s device delivers etanercept in pre-filled cartridges, and is designed to reduce injection-site pain for patients. Drug maker Takeda is also developing a novel delivery system; Takeda’s needle-free approach will allow patients to self-administer biologics using the device that will pressurize a liquid drug into a jet that pierces the skin on contact.
It remains to be seen whether Biocon’s novel packaging for its biosimilar will allow the company to claim additional market share for bevacizumab, but Biocon says that it hopes its quality-assurance system will give greater confidence to those administering the drug and will better ensure patient safety.
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 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.
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.
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.
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.