BIOCON PHARMA LIMITED

Alvotech and Teva's Selarsdi™, a biosimilar to Stelara®, was FDA approved on April 16, 2024, with a U.S. market entry by February 21, 2025. This marks the second Stelara® biosimilar approval, following Amgen's Wezlana™. Four other Stelara® biosimilars are pending approval. Stelara®'s 2023 U.S. sales were ~$6.97B.

The global Type 1 Diabetes (T1D) market is projected to grow at a CAGR of 17.2%, reaching US$ 38.63 Bn by 2029. Driven by increased awareness, technological advancements in insulin delivery, and government initiatives, the market faces challenges like high costs and biosimilars. North America leads, with APAC expected to grow significantly.

Biosimilars face limited competition, with discounts unlikely to exceed 50% soon. Indian and Chinese biosimilars struggle to enter the US market due to regulatory and quality issues, delaying significant price reductions. Big pharma remains dominant, maintaining higher prices with fewer biosimilars entering the market.

The Global Type 1 Diabetes - T1D Market Report 2024 provides insights into market size, CAGR, and industry statistics, segmented by type (Rapid Acting, Long Acting, Premix Insulin Analogs) and application (Children, Adults). It covers market dynamics, trends, opportunities, and competitive landscape, including key players like Novo Nordisk and Sanofi. The report offers regional and country-level analysis, with customizable segments and data available upon request.

The biosimilars market is projected to grow from $29.4 billion in 2023 to $66.9 billion by 2028, driven by a 17.8% CAGR. Key drivers include demand for cost-effective treatments, patent expirations, and rapid biosimilar approvals, especially in oncology. Challenges involve complex manufacturing and regulatory hurdles, with opportunities in Asia Pacific. Leading players like Novartis and Pfizer are shaping the market through innovation.

Biosimilars, similar to biologics in safety and efficacy, face complex production challenges. Regulatory frameworks vary globally, with the EU leading in biosimilar approvals. Biosimilars offer cost savings, with significant market growth expected as biologics' patents expire. The U.S. and EU are key markets, with biosimilars projected to save billions in healthcare costs.

India's CDSCO released revised biosimilar guidelines, and the Delhi High Court ruled Biocon and Mylan cannot label their trastuzumab versions as biosimilars to Roche's Herceptin, impacting biosimilar labeling and data exclusivity in India.