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Pearce IP BioBlast w/e 17 May 2024

Pearce IP BioBlast w/e 17 May 2024
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Samsung Bioepis Gains European Commission Approval For PYZCHIVA, a Biosimilar to Stelara (Ustekinumab)

Samsung Bioepis Gains European Commission Approval For PYZCHIVA, a Biosimilar to Stelara (Ustekinumab)
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Samsung Bioepis begins phase 3 clinical study for its Keytruda biosimilar

Samsung Bioepis, Samsung Group’s biosimilar arm, announced Friday that the company had started a phase 3 clinical study for SB27, a Keytruda biosimilar. Keytruda is an immuno-oncology drug developed by MSD, a US multinational pharmaceutical company. Indications for the drug include non-small cell lung cancer (NSCLC), melanoma and neck cancer. According to MSD's earnings release, global sales of Keytruda in.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and immunogenicity profiles were comparable between switching group and continuous reference product Humira group 52-week results from SB17 Phase 3 study demonstrated long-term efficacy, safety, and immunogenicity of SB17 compared to reference ustekinumab, including switching from ustekinumab to SB17 INCHEON,

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