BIOCON PHARMA LIMITED

In 2024, the FDA approved 17 Biologic License Applications, including groundbreaking treatments for cancer and genetic diseases, and 18 biosimilars. The Inflation Reduction Act's Medicare Drug Price Negotiation Program set reduced prices for 10 drugs. The FTC released an interim report on PBMs' impact on drug access and affordability. FDA issued guidances on biosimilar manufacturing changes, interchangeability, and promotional communications.

Ozempic and similar drugs, used off-label for weight loss, may address obesity in India. Regulatory and pricing challenges exist. Biocon advances in GLP-1 drugs. 2025 pivotal for India, with insights from experts on trends, economic growth, and global relations, aiming for higher per capita income.

Biocon's shares surged 8.5% to ₹389, driven by Japan's approval of its psoriasis drug Ustekinumab BS, developed by Biocon Biologics and marketed by Yoshindo Inc. Jefferies upgraded Biocon's stock to 'Hold' with a ₹400 target, citing USFDA's VAI status for its Bengaluru facility and upcoming biosimilar Stelara launch in 2025. The stock has recovered 87% from its low, yet remains 21% below its all-time high.

Insulin, crucial for diabetes treatment, faces pricing debates due to its cost surge over decades. The Affordable Insulin Now Act aims to cap insulin costs, amidst concerns over rationing and affordability. Biosimilars and innovations like glucose-sensitive insulin and cell therapy offer hope for cost reduction and better management, yet the pricing debate persists.

Jefferies upgraded Biocon to 'hold', raising its price target by 43% to Rs 400, citing FDA's approval of its Bengaluru unit and biosimilar Stelara's launch in 2025. Biocon's shares rose nearly 8%. The FDA's VAI status for Bengaluru and Stelara's approval are key growth drivers.

EMA's CHMP recommended approval of six biosimilars: Celltrion's AVTOZVMA, EYDENZELT, OSENVELT, STOBOCLO; Biocon's YESTINTEK; and CuraTeq Biologic's ZEFYLTI, targeting various diseases including arthritis, macular degeneration, cancer, osteoporosis, psoriasis, and neutropenia.

The oral proteins and peptides market is projected to grow from $1.04 billion in 2023 to $2.86 billion by 2028, driven by chronic diseases, biopharmaceutical advancements, and a shift towards non-invasive therapies. Innovations like Oral Semaglutide highlight the market's evolution towards patient-friendly treatments.

India's biopharmaceutical sector is poised for significant growth, aiming to lead in affordable medicines and complex biotherapeutics. With exports surpassing $2.3 billion in July 2024, the industry is crucial for global healthcare. Karnataka is becoming a biotech hub, supported by policies like Vigyan Dhara and BioE3, targeting innovation and sustainable development. Biocon achieved regulatory milestones, including MHRA and US FDA approvals for generics and biosimilars, enhancing access to advanced therapies.

Karan, a PhD scholar, secured funding for his 3D-printed organ technology by sharing his personal story, highlighting the importance of a compelling pitch in biotech research funding. The article outlines strategies for securing funding, including understanding the funding ecosystem, writing winning proposals, leveraging government grants, collaborating with industry, and exploring crowdfunding. It emphasizes persistence, adaptability, and the significance of aligning research with societal needs and investor interests.

Biocon Ltd shares rose 4.95% to ₹345.85 on NSE after receiving EU decentralised procedure approval for Liraglutide, a generic version of Victoza and Saxenda for Type-2 Diabetes and weight management. The stock closed at ₹343.15, up 4.13%, with a market cap of ₹41,252.62 crore.