Samsung Bioepis Receives FDA Approval for Pyzchiva, a Biosimilar to Stelara, for Multiple Inflammatory Conditions
Samsung Bioepis Co., Ltd. has achieved a significant milestone with the US Food and Drug Administration (FDA) granting approval to its Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe). Pyzchiva is now approved for both subcutaneous injection and intravenous infusion, serving as a biosimilar to Stelara (ustekinumab).
This approval encompasses the treatment of moderate to severe plaque psoriasis in patients eligible for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, Pyzchiva has received a provisional determination for interchangeability.
Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, emphasized the FDA’s decision as a pivotal advancement for patients grappling with inflammatory conditions. Jung highlighted the potential of biosimilars like Pyzchiva to expand treatment options and improve access to biologic therapies. She underscored the financial implications, noting that in the US, biologics constitute over 46% of annual drug spending, thereby suggesting that biosimilars could alleviate healthcare costs.
FDA approval for Pyzchiva was underpinned by comprehensive evidence, including analytical, non-clinical, and clinical data demonstrating its biosimilarity to Stelara. Key studies such as the phase 1 clinical trial (NCT04772274) showed equivalence in pharmacokinetics (PK) and comparable safety profiles between Pyzchiva (SB17) and Stelara in healthy volunteers. Moreover, the phase 3 trial (NCT04967508), conducted among patients with moderate to severe plaque psoriasis, affirmed the biosimilarity through equivalent efficacy, safety, and PK profiles up to Week 28. These findings were disseminated at the 2024 American Academy of Dermatology (AAD) Annual Meeting.
Moving forward, Pyzchiva will be commercialized in the United States by Sandoz, under an agreement between Samsung Bioepis and Sandoz effective from September 2023. The licensing period for Pyzchiva in the US is set to commence on February 22, 2025, pursuant to the settlement and license agreement with Janssen Biotech Inc.
Samsung Bioepis boasts a robust portfolio encompassing 11 biosimilars across various therapeutic areas including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. As of June 2024, seven biosimilars have received US approval, with four already commercially available.
Pyzchiva (ustekinumab-ttwe) is indicated for treating adults and pediatric patients aged 6 years and older with moderate to severe plaque psoriasis suitable for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.
Since its inception in 2012, Samsung Bioepis has remained dedicated to enhancing healthcare accessibility globally.