UPDATE : Monday, June 1, 2020
Biogen, Samsung Bioepis to present biosimilar data at EU conference
  • By Lee Han-soo
  • Published 2019.10.22 11:31
  • Updated 2019.10.22 11:31
  • comments 0

Biogen and Samsung Bioepis said that they plan to present new real-world data from the companies’ anti-TNF biosimilar portfolio, which includes Flixabi, an infliximab biosimilar, and Imraldi, an adalimumab biosimilar.

Samsung Bioepis' biosimilars Flixabi (left) and Imraldi

The company plans to present the data, which provides further insight into the long-term safety and efficacy as well as patient experience with anti-TNF biosimilars, at the United European Gastroenterology (UEG) Week 2019 taking place in Barcelona, Spain, from Oct. 19-23.

Biosimilars are products that demonstrate high similarities to reference biological product and have the potential to lower drug costs. In Europe, about 170,000 patients have received Biogen and Samsung Bioepis’ anti-TNF biosimilars. Biogen expects the uptake of these products to generate 1.8 billion euros in healthcare cost savings in 2019.

“Patients living with severe autoimmune diseases such as inflammatory bowel disease (IBD) are looking for long-term treatments to control symptoms and improve their quality of life safely and effectively,” said Professor Alessandro Armuzzi, the head of the IBD unit at Complesso Integrato Columbus Catholic University of Rome in Italy. “Biosimilars now open the door for more patients to access biologic medicines and effectively manage their gastrointestinal diseases.”

The two companies will present four abstracts at the EU conference, including clinical evaluation of the switch from reference adalimumab to Imraldi in 87 people with IBD – either Crohn’s disease or ulcerative colitis.

The study results showed a similar overall performance for the serum levels of adalimumab between Imraldi and reference adalimumab. Also, symptom activity indexes and inflammatory markers remained consistent after switching to Imraldi.

An interim analysis of the non-interventional PERFUSE study will also be presented.

The study investigated persistence -- the number of patients continuing on treatment -- and the immunogenicity of Flixabi in three subsets of IBD patients receiving Flixabi. These interim results demonstrate high persistence on Flixabi with no clinical differences observed (disease scores HBA or Simple Clinical Colitis Activity Index (SCCAI)) for the patients who transitioned.

“We plan to continue to research to generate data that will enable us to deliver value to patients with high unmet needs,” said Ian Henshaw, vice president and head of Biogen’s global biosimilars unit.

Han Seong-won, Samsung Bioepis vice president and medical team lead, also said, “We remain committed to advancing our strong pipeline of biosimilar candidates so that more patients and healthcare systems across the region will be able to benefit from biosimilars.”


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