Teva Pharmaceutical Industries

The biosimilars market is expanding, with the global market projected to hit $43.8 billion by 2024 and exceed $100 billion in a decade. Recent FDA and EMA approvals include biosimilars for Johnson & Johnson’s Stelara and Bayer’s Eylea, following patent expirations. Notable approvals include Pyzchiva, Ahzantive, Yesafily, Opuviz, Hercessi, Selarsdi, Wyost, Jubbonti, Simlandi, and Uzpruvo, targeting various conditions and expected to launch by 2025.

The "Dementia - Global Clinical Trials Review, 2024" report offers an overview of dementia clinical trials globally, including data by region, country, phase, status, and sponsor type. It highlights enrollment trends, key companies, and drugs in ongoing trials, aiding strategic decision-making and identifying business opportunities.

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.

Alvotech and Teva announced FDA approval of SELARSDI, a biosimilar to Johnson & Johnson’s STELERA®, for treating moderate to severe plaque psoriasis and psoriatic arthritis. SELARSDI, developed by Alvotech and commercialized by Teva, is the second ustekinumab biosimilar approved by the FDA, following Amgen’s WEZLANA.

TEVA leverages its strong generic drug portfolio and innovative treatments in CNS, oncology, and respiratory areas for competitive advantage. Its 'Pivot to Growth' strategy focuses on enhancing global commercial and R&D capabilities. Despite facing intense competition, price pressures, and macroeconomic challenges, TEVA sees opportunities in biosimilars and market diversification. Regulatory compliance and geopolitical risks remain significant threats.

The FDA is seeking new suppliers for methotrexate, a cancer drug in short supply due to disruptions from India-based Intas Pharmaceuticals. Shortages also affect cisplatin and carboplatin. Over 130 drug formulations are currently in shortage in the U.S. Methotrexate inhibits cancer cell growth and immune system activity.

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.

BIO 2005 highlighted global biotech advancements, with significant contributions from countries outside the USA and Western Europe. Latin America, Asia-Pacific, and Eastern Europe showcased their biotech industries, emphasizing economic growth, innovation, and international collaboration. The event underscored the global biotech race, with nations investing heavily in research and development to secure a competitive edge.