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Pearce IP BioBlast w/e 17 May 2024

Pearce IP BioBlast w/e 17 May 2024
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Transactions with Affiliated Companies | Company Announcement

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.

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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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