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Stada Waits For SPC Expiry Before Launching First Stelara Biosimilar In EU

 
• By Ian Schofield

The approval of a biosimilar version of ustekinumab could “significantly expand access to this life-changing biologic therapy,” according to Stada and Alvotech.

Traffic light on green
The EU has given the green light to a Stelara biosimilar • Source: Shutterstock

The European Commission has approved Stada/Alvotech’s Uzpruvo (ustekinumab), the EU’s first biosimilar version of Janssen’s originator drug Stelara, for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

The EU marketing authorization (MA) “paves the way for market entry as soon as possible” following the July 2024 expiry of a supplementary protection certificate (SPC) on Stelara, the companies...

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More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.