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Home Industry News Pharmaceutical Samsung Bioepis Secures FDA approval for Stelara biosimilar
drug discovery

Samsung Bioepis Secures FDA approval for Stelara biosimilar

2nd July 2024

The FDA has approved PYZCHIVA to be a biosimilar of Stelara, according to Samsung Bioepis. Its biosimilarity to Stelara is confirmed by extensive information, which forms the basis of the approval.

This covers non-clinical, analytical, and research findings that do not demonstrate appreciable variations in terms of potency, purity, or safety.

In healthy participants, a Phase I clinical investigation showed that PYZCHIVA and Stelara had similar immunogenicity characteristics, protection, and pharmacokinetic equivalency. The biosimilarity of SB17 to Stelara was further substantiated by clinical findings from a Phase III study comprising individuals with mild to serious plaque psoriasis.

Samsung Bioepis vice-president and regulatory affairs team leader Byoung In Jung commented: “The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments.

They continued: “In addition, biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the US where biologics account for more than 46% of the annual drug spending.”

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