iQone Healthcare Switzerland is offering a range of biological and biosimilar therapies to address unmet medical needs. What they are is explained hereafter.

BIOLOGICS
Biological medicines, or biologics, are genetically engineered proteins produced by living cells such as cloned human white blood cells. They are called biological medicines because they mimic substances produced by the human body such as antibodies. They are designed to target specific molecules of the immune system involved in inflammation. Since the late 1980s, biologics have been used as highly-effective and human-friendly treatments for patients and caregivers in autoimmune diseases, cancer and chronic diseases.

BIOSIMILARS
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’ or ‘originator product’). Biosimilars have no clinically meaningful differences in purity, immunogenicity, safety and effectiveness from the reference product. They have the same structure as their parent biologics and are approved by health authorities according to the same standards that apply to all biological medicines. As clones of high-priced biologics, biosimilars provide the same therapeutic effects at affordable prices, improving access to medical treatment to patients in need.

MEDICAL PUBLICATIONS
Clinical studies show the efficacy and safety of switching from originator to biosimilar (CT-P13) Infliximab in several immunologic indications (rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis).

HEMATOLOGY & ONCOLOGY

TO COME

IMMUNE DISEASES

iQone Healthcare Switzerland’s immunology franchise is committed to bring new prescription medicines to address a range of autoimmune disorders. These are rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, psoriasis and psoriatic arthritis.

Today innovative treatments are being developed that bring hope to patients around the world by targeting chemicals involved in immune responses with greater specificity and fewer side effects.

IMMUNOLOGY PRODUCT LIST

Infliximab is the world’s first monoclonal-antibody biosimilar developed by Celltrion Healthcare. It is a therapeutic medicine for autoimmune diseases and is indicated for treating rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, psoriasis and psoriatic arthritis. It works by neutralizing a physiological compound called tumor necrosis factor alpha (TNF-alpha) that regulates inflammation.
Infliximab has received its market authorization in 80 countries including Europe, USA, Canada, Japan and South Korea

PATIENT COACHING

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PIPELINE

Our partner Celltrion Healthcare is developing several new biosimilars and biologics

MONOCLONAL – ANTIBODY BIOSIMILARS:

PROJECT INN1 Mechanism of action Major indications
Remsima SC / CT-P13 Infliximab TNF-α inhibition Rheumatoid arthritis, IBD
CT-P05 Etanercept TNF-α inhibition Rheumatoid arthritis
CT-P14 Palivizumab Prevention of RSV2 Respiratory diseases
CT-P15 Cetuximab EGFR inhibition Colorectal cancer
CT-P16 Bevacizumab VEGF inhibitio Colorectal cancer
CT-P17 Adalimumab VEGF inhibition Rheumatoid arthritis

Anticancer mAb biosimilar approved by FDA, EMA and MFDS:

Brand name INN Indication
Herzuma Trastuzumab HER 2 positive metastatic breast cancer, early cancer, and metastatic gastric cancer

ANTIBODY BIOLOGICS:

PROJECT MOLECULAR TYPE TARGET INDICATION
CT-P27 Monoclonal antibody Pandemic / seasonal influenza
CT-P26 Antibody-drug conjugate Breast cancer
CT-P19 Monoclonal antibody Rabies
CT-P24 Monoclonal antibody Hepatitis B virus
CT-P25 Cell culture vaccine Influenza

PUBLICATIONS

The following articles relate to clinical studies showing the same efficacy and safety of the biosimilar infliximab CT-P13 compared to the reference product.

Pivotal trials:
• Planetas study comparing CT-P13 and innovator infliximab in ankylosing spondylitis over 30 weeks. By Park W, 2013
• Planetas extension study in AS over 54 weeks. By Park W, 2016
• Planetas extension study in AS over 102 weeks. By Park W, 2016
• Planetra study comparing CT-P13 and innovator infliximab in rheumatoid arthritis over 30 weeks. By Yoo DH, 2013
• Planetra extension study in RA over 102 weeks. By Yoo DH, 2016

Post-approval trials:
• Jörgensen NORSWITCH P483 Long term follow up ECCO 2018
• NorSwitch trial Joergensen 2017

The following articles give detailed information about biosimilars.
• Overview of biosimilar medications. By Lyman GH, 2018
• Taberno esmoopen-2016-000142

Pivotal trial with reference and biosimilar Rituximab:
• Switch from RP to CT-P10 in RA. By Park W, 2018