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Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

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Fresenius Kabi

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Shots: The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval PB016 is…

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Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…

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Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots: Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…

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