USFDA final approval for Lanreotide injection

News: Cipla has received USFDA final approval for its Lanreotide Injection in strengths of 60mg/0.2mL, 90mg/0.3mL and 120mg/0.5mL, single dose pre-filled syringes. This approved NDA (505(b)(2) pathway) is indicated for the treatment of patients with Gastrointestinal Tumors (GEP-NETs).

View: The active ingredient, route of administration and strengths for approved drug are the same as the reference drug with market size of ~ US$867 million (MAT October 2021, IQVIA). This approval is in line with the company’s aspiration for more complex products in the US. US business has grown at a CAGR of 15% from FY16-21 and contributed 20% to total revenue in FY21. We remain positive on Cipla’s calibrated approach of focusing more on branded products and core therapies across the world

Impact: Positive