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Sandoz Launches Pyzchiva Autoinjector in Europe: A First for Ustekinumab Biosimilars

26 May 2025
Admin
News Article

Sandoz Launches Pyzchiva Autoinjector in Europe: A First for Ustekinumab Biosimilars

Sandoz, a global leader in generics and biosimilars, has announced the European launch of its Pyzchiva (ustekinumab) autoinjector — marking the first ustekinumab biosimilar in Europe to be made commercially available in an autoinjector format.

About Pyzchiva: A New Option for Chronic Inflammatory Diseases

Developed and registered by Samsung Bioepis, Pyzchiva is approved to treat:

Adults with plaque psoriasis
Psoriatic arthritis
Crohn’s disease
Pediatric plaque psoriasis (for patients aged 6+ years, weighing over 60 kg)

Features of the Pyzchiva Autoinjector

Designed to support better self-administration and adherence, the Pyzchiva autoinjector offers:

Accurate automatic dosing
Reduced injection pain
Compact, ergonomic design
Flexible storage options

These features aim to enhance the comfort and convenience of patients managing chronic inflammatory diseases.

Christophe Delenta, President - Europe, Sandoz:

"Access to medicine does not end when it reaches the hands of the patient... This launch marks another important milestone as we strengthen our leadership in immunology biosimilars and reaffirm our commitment to pioneering access across Europe’s evolving healthcare landscape."

Addressing Real-World Needs

Psoriasis: Affects approximately 6.4 million people in Europe
Inflammatory Bowel Disease (IBD): Impacts an estimated 2.5 to 3 million Europeans

The Issue of Non-Adherence

Non-compliance with biologic therapy may result in:

Disease progression
Increased flare-ups
Reduced quality of life
Higher healthcare costs due to more frequent hospitalizations and treatments

Pyzchiva’s Strategic Role in Sandoz Growth

Launched in 23 European markets
Currently available in Spain, with wider rollout across Europe underway

Partnership with Samsung Bioepis

Signed in September 2023
Sandoz holds commercialization rights in:
- Brazil
- The United States
- European Economic Area (EEA)
- Switzerland
- United Kingdom
Samsung Bioepis retains responsibility for:
- Development & registration
- Intellectual property
- Manufacturing & supply

Pyzchiva Formulations & Delivery

Available Formats

Autoinjector (Molly platform by SHL Medical AG):
- 90 mg in 1 mL
- 45 mg in 0.5 mL
Other Forms:
- 130 mg concentrate in a vial (solution for infusion)
- 90 mg & 45 mg in pre-filled syringes (solution for injection)

Comparable to Stelara

Pyzchiva is a biosimilar to the reference medicine Stelara, a human monoclonal antibody targeting interleukin pathways. It demonstrates equivalent efficacy and comparable safety