Enzene Biosciences launches ranibizumab as an affordable alternative to treat neovascular AMD

After launching bevacizumab for the treatment of metastatic colorectal cancer, Pune-based Enzene Biosciences has now followed it up with the launch of ranibizumab, a biosimilar to innovator product Lucentis that is sold under the brand name Accentrix in India.

A recombinant Fab that is used as a therapy for neovascular age-related macular degeneration (AMD), the ranibizumab biosimilar is the company’s 7th biosimilar and could significantly lower treatment costs for thousands of Indian patients.

As established in phase 3 clinical studies, Enzene’s ranibizumab biosimilar showed comparative clinical efficacy with Lucentis and is produced using the company’s state-of-the-art MAR system at its plant in Chakan, Pune.

Speaking on the launch of its 7th biosimilar in the Indian market, Dr Himanshu Gadgil, CEO, Enzene Biosciences added, “Enzene Biosciences reaffirms its dedication to providing reliable and affordable medicines with the introduction of our ranibizumab biosimilar. As a people-focused company, we recognize human capital as our most valuable asset. Prior to ranibizumab, our teams have successfully delivered six commercial biosimilars and supported our partners with clinical supplies of novel biologic entities (NBE’s), such as monoclonal antibodies (mAbs) and multi-specific molecules. Additionally, we’ve pioneered the EnzeneX platform, a leading commercial continuous manufacturing platform. The successful commercialization of ranibizumab, a recombinant Fab, stands as a testament to the exceptional skills of our technical teams.”

Enzene Biosciences is another step closer to establishing itself as a globally recognized biosimilar company, with an unmatched track record of developing and launching innovative biosimilars in record time. Enzene’s Chakan fill finish facility utilizes automated robotic arms that support in filling these biosimilar products in pre-sterile ready to use vials, with minimal manual intervention ensuring better process controls and consistently high-quality standards.

In fact, Enzene’s ranibizumab matches competitors in terms of product purity and is designed to bind and inhibit vascular endothelial growth factor (VEGF-A), thereby interrupting the interaction of VEGF with its receptors. This is extremely important in treating patients with macular edema following retinal vein occlusion (RVO), diabetic macular edema as well as neovascular AMD since VEGF is the biochemical signal protein that promotes angiogenesis throughout the eye and other parts of the body.

Sharing his enthusiasm about the large strides made by Enzene in the biosimilar space, Sandeep Singh, MD, Alkem Industries commented, “It gives me immense pride to see Enzene Biosciences bringing to market another important biosimilar. With ranibizumab, Enzene has once again demonstrated how we can enable accelerated product development, while also reducing costs for the end consumer. After successfully establishing ourselves in the Indian biosimilar space, we are now looking to broaden our footprint globally through organic growth as well as strategic acquisitions.”

In addition to its recent releases, Enzene is actively progressing with the development of three additional biosimilars in various stages. Furthermore, the company is in alliance with UK-based pharmaceutical firm Theramex to launch a biosimilar of Prolia in Europe, UK, Australia and Switzerland. Enzene Biosciences is also developing a synthetic peptide pipeline and is focused on supplementing its manufacturing capabilities, with plans to expand into key international markets like the USA, at a rapid pace.

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