First Biosimilar for Head and Neck Cancer Treatment

MUMBAI, India I May 30, 2023 I Global pharma major Lupin Limited (Lupin) today announced a strategic collaboration with Enzene Biosciences to launch Cetuximab in India, the first biosimilar developed for Cetuximab. This collaboration marks a significant milestone in expanding therapeutic options and fostering innovation in the critical area of treatment of head and neck cancer. Cetuximab has received approval from the Drug Controller General of India (DCGI) for its effectiveness in treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN), making it a crucial solution for patients with recurrent locoregional or metastatic conditions. Cetuximab is available as a 100mg vial.

Head and neck cancer presents a significant public health challenge in India, with a staggering annual incidence of over 100,000 new cases. This malignancy affects critical regions of the head and neck, including the oral cavity, pharynx, larynx, and sinuses. The disease is often diagnosed at advanced stages, making effective treatment increasingly challenging. As a result, head and neck cancer carries a substantial burden, leading to significant difficulties in providing effective treatment and resulting in high mortality rates.

Commenting on the launch, Rajeev Sibal, President – India Region Formulations, Lupin said, “The launch of first biosimilar Cetuximab reflects our steadfast dedication to improving access to solutions and enhancing patient outcomes. Through this collaboration, we empower healthcare professionals with a transformative and affordable solution that holds the potential to make a significant impact on the lives of those facing this challenging disease.”

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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About Enzene Biosciences Ltd
Enzene is an innovation-driven biotech company a subsidiary of Alkem Laboratories Ltd. (one of the top five pharmaceutical companies in India*) located in Pune, India. Enzene’s focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. Enzene also offers a range of biologics CDMO and CMO services with capabilities from clone development up to GMP manufacturing supported by bioreactor capacities ranging from 20 litres to 2000 litres.
*Source: IQVIA data March 2022