INDIA – Enzene Biosciences Limited, the biological arm of Alkem Laboratories, is looking to gain ground in India’s biosimilars market with the launch of its new product Ranibizumab.
Enzene Biosciences has pledged to invest up to US$50 million in setting up a production facility in the United States, with construction works expected to start in 2024.
Following the launch of Ranibizumab, Enzene Biosciences will not only enhance its biosimilar presence in the Indian subcontinent but also its leadership position in the global biosimilars industry.
The company has already launched six biosimilars, including Teriparatide for osteoporosis, and Denosumab used to treat postmenopausal osteoporosis and giant cell tumours of bone.
Taking into account its Romiplostim for immune thrombocytopenic purpura and Adalimumab for rheumatoid arthritis.
The existing commercialized portfolio of biosimilars also includes Bevacizumab, a biosimilar version of Roche’s Avastin, and Cetuximab, a type of targeted cancer drug.
Moreover, Enzene Biosciences plans to launch Ranibizumab, a biosimilar of Lucentis, marking its milestone 7th biosimilar product in the Indian market.
In an official statement, Himanshu Gadgil, Chief Executive Officer of Enzene Biosciences Limited said: “Ranibizumab is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration edema following retina vein occlusion and diabetic macular edema.”
As a wave of biosimilar products is accelerating into the US marketplace, Enzene Biosciences has focused on the marketing of these medicines in India and then to the US market.
Enzene Biosciences is set to introduce its Ranibizumab to serve as an alternative to the originator product Lucentis.
Lucentis is a humanized monoclonal antibody fragment and recombinant humanized lgG1 isotype designed to bind and inhibit vascular endothelial growth factors.
Enzene Biosciences will soon launch its biosimilar of Lucentis as a way to bring new therapeutic options for patients with severe eye conditions.
With this launch, the company inches closer to realizing its sole mission of delivering innovative and affordable biomanufacturing for novel biologics and biosimilars globally.
The company has started work on Pertuzumab, a biosimilar for Perjeta for breast cancer, while Tocilizumab for rheumatoid arthritis is in the pipeline.
With multiple drugs going off the patent list in 2026-2028, Enzene Biosciences has started working on biosimilars for the soon-to-be-launched affordable drugs.
The expected product launches come shortly after Enzene Biosciences patented a connected continuous biologics manufacturing facility to monoclonal antibodies (mAb) in Pune.
“The company will pursue launching two biosimilars every year. Enzene Biosciences has patented a process for continuously manufacturing these biosimilars, enabling us to reduce costs and speed up production,” stated Gadgil.
The Pune facility has a significantly smaller footprint than the conventional manufacturing facilities and has lower manufacturing costs with higher production capabilities.
On his part, Himanshu Gadgil pointed out that Enzene Biosciences recently expanded its Research & Development capability with a new facility at Chakan in the Pune district.
The Chakan facility offers fully integrated services through the specialized departments established by Enzene Biosciences.
These integrated services include Cell Line Engineering (CLE), Drug Product Development (DPD), Purification Process Development (PPD), Advanced Analytical Technology (AAT), and Bioanalytical Assay.
Gadgil further said that the Chakan facility integrates an open lab set-up to promote cross-departmental collaboration and knowledge-sharing opportunities.
In addition to its own product portfolio, Enzene Biosciences is working with US-based companies on 31 projects offering CDMO (contract development and manufacturing organisation) services for biologics from its India facilities.