• In February 2025, Novartis launched a next-gen calcineurin inhibitor with reduced nephrotoxicity profile, aimed at kidney transplant patients. This innovative therapy represents a significant advancement in transplant immunosuppression by addressing one of the most critical long-term complications—nephrotoxicity. The drug aims to maintain effective immunosuppression while preserving renal function, enhancing long-term graft survival and patient quality of life. It is expected to become a preferred option in both initial and maintenance transplant regimens.
• In October 2024, Astellas received FDA approval for an extended-release tacrolimus formulation to improve dosing adherence. Designed for patients requiring long-term immunosuppression, this once-daily formulation simplifies treatment schedules, reduces peak-trough fluctuations, and enhances compliance. Especially beneficial for kidney and liver transplant recipients, the new formulation supports more stable drug levels and reduces the likelihood of rejection episodes tied to missed doses.
• In August 2024, Roche initiated Phase II trials for a novel interleukin-6 monoclonal antibody targeting systemic lupus erythematosus. This investigational biologic targets IL-6, a cytokine implicated in the inflammatory cascade associated with lupus. The therapy is designed to reduce disease flares and organ damage while offering a more tolerable safety profile than existing options. If successful, it could address unmet needs in the treatment of moderate to severe systemic lupus erythematosus (SLE), a market with high demand for safer, more effective biologics.
• In May 2024, Sanofi entered a licensing deal with a biotech firm to co-develop a biosimilar of adalimumab for emerging markets. The strategic partnership focuses on expanding access to high-cost biologic therapies by developing a cost-effective biosimilar of adalimumab, a leading anti-TNF agent used in autoimmune conditions. This move supports Sanofi’s objective to penetrate emerging markets where affordability remains a key barrier to biologic adoption, thus driving global immunosuppressant accessibility.
• In March 2024, Pfizer opened a new biologics manufacturing facility in Singapore focused on scaling immunosuppressive antibody therapies.The state-of-the-art facility will enhance Pfizer’s global biologics supply chain and support the production of next-generation monoclonal antibodies used in autoimmune and transplant therapy. This investment reinforces Pfizer’s long-term commitment to biologics and expands its footprint in the Asia-Pacific region, addressing growing regional demand and supporting rapid market response to global supply needs.
