Stelara is the brand name for ustekinumab, a human interleukin-12 and interleukin-23 antagonist used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The label includes adult and pediatric indications depending on disease area. U.S. initial approval was in 2009, with recent indication updates in 2026.
Johnson & Johnson agreed to buy Firefly Bio for $1 billion to advance KRAS-targeted cancer therapies. The company also announced a $1 billion cell therapy manufacturing plant in Pennsylvania as part of a $55 billion US investment plan.
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
The US FTC is challenging a court ruling involving Johnson & Johnson's patent acquisition for Stelara, arguing it could weaken antitrust enforcement in pharma. Separately, Turkey's Court of Cassation ruled that patent holders who file infringement actions and send warning letters to third parties are exercising lawful patent rights, dismissing an unfair competition claim by a generic company.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
Johnson & Johnson said revenue could reach about $100.5 billion at the midpoint in 2026 after 2024 net sales rose 6% to $94.2 billion. The company faces talc litigation, Stelara patent losses and U.S. drug price negotiations.
Johnson & Johnson shares hit a 52-week high after the company reported 2025 revenue of $94.19 billion and forecast 2026 revenue above $100 billion. The company also filed a shelf registration and said Innovative Medicine growth offset pressure from Stelara.
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05890118 |
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule |
COMPLETED | PHASE1 |
| NCT05335356 |
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis |
COMPLETED | PHASE3 |
| NCT04930042 |
Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis |
COMPLETED | PHASE3 |
| NCT04785326 |
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis |
COMPLETED | PHASE3 |
| NCT04673786 |
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis |
COMPLETED | PHASE3 |
| NCT03651518 |
Personalized Therapies in Inflammatory Complex Disease |
COMPLETED | PHASE2 |
