Guselkumab

As patent cliffs loom and pricing scrutiny intensifies, pharmaceutical giants are doubling down on innovation pipelines and international expansion. The first quarter of 2025 saw mixed results among major players like Merck, Roche, Sanofi, Bristol Myers Squibb (BMS), and Johnson & Johnson, with several breakthrough drugs pulling weight while legacy products faltered.   Merck reported $15.53 billion in total revenue, a 2% year-over-year decline, largely driven by a steep 62% drop in China sales. Its blockbuster immunotherapy Keytruda remains dominant, bringing in $7.21 billion (up 4%), nearly half of the company’s total revenue. A new subcutaneous formulation—which cuts injection time to just two minutes—is currently under U.S. and EU review. Meanwhile, Gardasil vaccine sales slid 41%, mostly due to China’s lingering stockpiles.   Roche posted $17.24 billion in Q1 revenue, with pharma growing 8% to $13.34 billion. China was a highlight, showing double-digit growth. Biologics like Phesgo, Vabysmo, Xolair, and Hemlibra crossed the billion-dollar mark. The company also announced the start of a Phase III Alzheimer’s trial while axing three other pipeline projects.   Sanofi’s revenue reached $10.46 billion, growing nearly 10%, led by strong U.S. performance (+15.4%). China revenues, however, slipped 1.7%. Its R&D spend was nearly $1.91 billion, funding major regulatory milestones in asthma, autoimmune, and neurodegenerative diseases, with seven pivotal trial updates expected in the second half of 2025.   BMS faced a 6% decline, totaling $11.2 billion in Q1. However, its new portfolio outperformed: Opdivo, Breyanzi, and Camzyos led a 16% growth in newer therapies. The company is now forecasting up to $46.8 billion in 2025 revenue. CAR-T product Breyanzi and KRAS inhibitor Krazati were top growers, while legacy drugs like Abraxane and Revlimid fell sharply.   Johnson & Johnson exceeded expectations with $21.9 billion in revenue (+2.4%). Strong gains from Darzalex, Carvykti, and Tremfya compensated for steep declines in Stelara (-34%) due to generic erosion. New combo therapies and oral biologic alternatives in late-stage development are expected to fuel momentum into 2026.   From regulatory wins to strategic pipeline shifts, Big Pharma is moving fast to realign for post-patent growth. But China’s sluggish demand and trade-related tariffs will remain drag factors as the year unfolds.

Johnson & Johnson (J&J) has shared positive long-term results from a phase 3 trial of its dual-acting IL-23 inhibitor Tremfya (guselkumab) in patients with ulcerative colitis (UC). The QUASAR long-term extension study has been evaluating the drug in adults with moderately to severely active UC who have had an inadequate response, or been intolerant, to conventional therapy, prior biologics and/or Janus kinase (JAK) inhibitors. Results presented at this year’s Digestive Disease Week (DDW) showed that 72% of patients were in clinical remission at week 92, with 99% of these patients remaining corticosteroid free for eight or more weeks. Endoscopic remission was achieved by 43% of patients at week 92 and, among those achieving endoscopic improvement at week 44, 84% maintained endoscopic improvement to week 92. These benefits were seen in patients regardless of prior biologic and/or JAK inhibitor treatment history, J&J said, adding that safety data from the trial was “consistent with the well-established safety profile of Tremfya in inflammatory bowel disease (IBD)”. More than 2.5 million people in Europe are affected by UC, one of the two main forms of IBD. Patients can experience a range of unpredictable symptoms, including loose and more frequent bowel movements, bloody stools, abdominal pain and loss of appetite. Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and received approval from the European Commission last month to treat adults with moderately to severely active UC. The drug is also approved in the US for the same indication. Esi Lamousé-Smith, vice president, gastroenterology disease area lead, immunology, J&J Innovative Medicine, added: “With these findings, Tremfya shows the powerful impact it can have in achieving longer term remission in patients.” Alongside data from QUASAR, J&J presented at DDW positive new results from the phase 3 ASTRO study of Tremfya subcutaneous (SC) induction therapy in adults with moderately to severely active UC. For the treatment of UC, the drug is currently administered via an intravenous (IV) induction regimen, followed by a SC maintenance regimen. It is hoped that SC and IV induction options would give patients and healthcare professionals greater flexibility.