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.