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BioFactura Completes Phase I For Late-To-Market Stelara Biosimilar

Firm Aims To File Biosimilar Ustekinumab Candidate In Developed Markets In 2026

 
• By Chloe Kent

BioFactura has completed a successful Phase I trial of its Stelara (ustekinumab) biosimilar BFI-751, which is expected to file in developed markets in 2026.

Hand pushing wooden block signifying phase 1, positioned above blocks signifying phase 2 and 3
Analysts estimate that BioFactura's ustekinumab represents a $50m market opportunity • Source: Shutterstock

A decade on from Celltrion’s groundbreaking European approval for Remsima (infliximab) – the world’s first biosimilar monoclonal antibody, developed under the codename CT-P13 – the company is launching a campaign to celebrate what it describes as “a decade of continuous biosimilar innovation in Europe.”

With the campaign aiming to highlight the positive impact of biosimilars to patients and healthcare systems – whilst also “reflecting on what the future could hold through continued innovation” – Celltrion is arranging a global speaker tour, presentations by key opinion leaders showcasing the latest clinical data, a report highlighting “a decade

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Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By Dave Wallace

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

More from Products

Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.