Bio-Thera Expands Partnership with Intas for Golimumab Biosimilar in India

Bio-Thera Solutions has announced a further expansion of its partnership with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, through an exclusive commercialization and license agreement for India. This marks Bio-Thera's first biosimilar partnership for India, which the company views as an important growing market with many patients that can be helped by BAT2506 and other biosimilars in its pipeline.

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

The India biosimilars market is estimated to grow from USD 184 million in the current year to USD 1.02 billion by 2035 at a CAGR of 21% during the forecast period. The growth of the biosimilars market in the coming decade is projected to be fueled by the expiration of biologics patents, resulting in the development of alternative biosimilars that closely resemble their reference biologics.

Currently, monoclonal antibodies segment captures nearly 55% of the overall market share in India. This dominance can be primarily attributed to their extensive use in treating chronic conditions like cancer, rheumatoid arthritis, and other autoimmune disorders. At present, majority (~40%) of the market share of biosimilars in India is held by oncological disorders, due to the increasing cancer burden.

The India biosimilars market experiences robust growth driven by several key factors, including rising prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders and increased demand for affordable biologic alternatives. Government initiatives such as streamlined regulatory pathways via the Central Drugs Standard Control Organization (CDSCO) and incentives under the PLI (Production Linked Incentive) Scheme for biologics also propel market growth.

Strategic partnerships with global firms, low-cost manufacturing capabilities, and a skilled workforce further position India as a leading exporter. However, challenges persist in the India biosimilars market despite the ongoing market growth, including high development costs, complex manufacturing processes requiring stringent quality controls, and risks of immunogenicity or structural variability.