This Week’s Biopharma News: EU Clears First Pertuzumab Biosimilar - Takeaways - MDSpire

This Week’s Biopharma News: EU Clears First Pertuzumab Biosimilar

  • May 5, 2026

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  • 1

    The EU has approved the first pertuzumab biosimilar, POHERDY, for HER2-positive breast cancer, expanding treatment options in Europe.

  • 2

    POHERDY's approval is based on comprehensive data demonstrating high similarity to Roche's PERJETA, including efficacy and safety.

  • 3

    Genexine's GX-BP1 shows strong preclinical activity in resistant cancer models, achieving up to 96% tumor growth inhibition in combination therapies.

  • 4

    NICE has recommended rozanolixizumab as the first treatment for uncontrolled generalized myasthenia gravis in adults, available through interim funding.

  • 5

    Ecolab has opened a Bioprocessing Applications Lab in Korea to support biopharmaceutical manufacturers in optimizing purification workflows.

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