Enzene Biosciences launches Cetuximab: the first biosimilar of cancer treatment drug Erbitux

New Delhi: Trusted worldwide for delivering quality and affordable medicines by virtue of its manufacturing excellence, Pune-based Enzene Biosciences has launched Cetuximab as the first biosimilar to cancer.

Sold under the brand name Erbitux, Cetuximab is a therapeutic chimeric monoclonal antibody that is used as a targeted therapy for metastatic colorectal Cancer (mCRC) and cancer of the head and neck, with eight weeks of treatment costing about $30,000 for a single patient.

However, after past patent expiry, several companies were in the race to develop Cetuximab’s biosimilar in order to bring down the costs of treatment. Enzene Biosciences has earned the distinction of being the first company to achieve this goal, thereby leading the charge in helping fight the third most common and the second largest cause of deaths due to cancer across the world today.

Known to account for 10% of global cancer incidence and almost the same contribution in cancer deaths, common treatment for colorectal cancer includes surgery, chemotherapy and radiation therapy. However, two companies have cemented their duopoly over the manufacture and distribution of Cetuximab, undoubtedly impacting access to affordable medications for those in need. What’s more, since Erbitux is manufactured using mouse cell lines that results in the production of protein containing non-human-like glycan structures, the chance of immunogenicity in individuals who are sensitive to mouse antigens is high thereby leading to immunogenicity-related adverse effects. Enzene’s Cetuximab is produced in Chinese Hamster Ovary (CHO) cell line; resulting in glycosylation profiles that are more human-like. This has led to lower incidence of adverse effects in clinical trials in India.

Commenting on the launch of Cetuximab, Dr Himanshu Gadgil, CEO, Enzene Biosciences, added, “Recognizing the fact that biosimilars are an innovative alternative to expensive biologics as a treatment option for a wide range of ailments like cancer, we at Enzene Biosciences have been developing a range of biosimilars for the US, EU, APAC, MENA and LATAM regions. Cetuximab is our latest offering in our pipeline of biosimilars, that is being manufactured using our patented continuous manufacturing platform and will considerably bring down the treatment costs for mCRC and cancer of the head and neck for our Indian patients.”

Cetuximab binds to specific cancer cell surface receptors (EGFR) and competitively inhibits the epidermal growth factor (EGF) binding. Acting like an inhibitor to prevent cell growth and metastasis, Enzene’s Cetuximab has potentially less risks for patients and will be marketed at a cost, several folds lower than the usual cost of the biologic Cetuximab. This advantage can be attributed to Enzene’s pioneering efforts in Continuous Bioprocess Manufacturing and extends the legacy of parent company Alkem Laboratories Ltd, known as India’s generic and specialty pharmaceutical forerunner with a global presence.

Elaborating on how Enzene is positively impacting humankind, Sandeep Singh, MD, Alkem Industries stated, “Alkem has been at the forefront to bringing drugs into the Indian market for many years. With the strongest pipeline of biosimilars in the country, Enzene Biosciences has already launched 5 such Biosimilars in a short span of 24 months and is on track to launching 2 more in the next few months. We aspire to aggressively promote Cetuximab, an affordable option to Erbitux for our Indian patients with head and neck cancer. Moreover, Enzene is committed to continue working on such innovative technologies to combat the rising prices of essential drug molecules and alleviate the financial burden borne by affected Indian patients and many more across the globe.”

Operating as an independent company within the Alkem group, Enzene Biosciences is fast emerging as an important biotechnology company that is leveraging disruptive innovation to enhance global health.