Reflecting on our journey this year , we are proud to share remarkable milestones and regulatory achievements that have defined the first half of 2024 for Samsung Bioepis.
We are thrilled to announce that, in July, we secured our eighth U.S. Food and Drug Administration (FDA)-approved biosimilar. This achievement brings us closer to our mission of expanding patient access to affordable and accessible treatment options in areas with unmet medical needs.
In just three months, between May through July 2024, we have achieved three Biologics License Applications (BLA) approvals with aflibercept, eculizumab, and ustekinumab biosimilars. Additionally, our adalimumab biosimilar has been granted interchangeability designation by the FDA for low-concentration pre-filled syringe and low-concentration vial presentations.
In Europe, we celebrated another milestone with the European Comission (EC) approving our eighth biosimilar, the ustekinumab biosimilar, in April 2024.
EPYSQLI™, Expanding Our Footprint into Rare Diseases
- In March 2024, the European Commission (EC) approved an expanded indication for EPYSQLI, a biosimilar to Soliris (eculizumab), for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS). Initially, in May 2023, EPYSQLI had been granted marketing authorization by the EC for treatment of adult and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH). In July 2024, EPYSQLI (eculizumab-aagh) was also approved by the FDA as a biosimilar to Soliris (eculizumab), marking Samsung Bioepis’ eighth biosimilar approved by the FDA.
“EPYSQLI is our first approved biosimilar for hematology/nephrology, strengthening our commitment to expand into rare disease areas that often lack affordable and sustainable treatment options with limited access.” |
OPUVIZ™, One of First Interchangeable Biosimilars to Eylea
- In May 2024, the FDA approved OPUVIZ (aflibercept-yszy) as one of the first interchangeable biosimilars to Eylea (aflibercept). With this approval, Samsung Bioepis now has two ophthalmology biosimilars approved by the FDA, marking an important step towards expanding treatment options for patients suffering from retinal disorders.
PYZCHIVA™, One of First-Wave Ustekinumzab Biosimilars In Europe
- In April and June of 2024, our ustekinumab biosimilar, PYZCHIVA, was successfully approved by both the EC and FDA respectively. In the U.S., the FDA has also granted provisional determination for the interchangeability of PYZCHIVA. Our efforts to widen patients’ access have allowed us to be the first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130mg vial initiation dose for Crohn’s disease with the launch of PYZCHIVA across Europe by our partner Sandoz in July 2024.
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Byoungin Jung, Vice President and Regulatory Affairs Team Leader, Samsung Bioepis: “It is exciting to see the growing number of biosimilar approvals in the U.S., Europe, and other major markets. |