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Polpharma

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A Polish CDMO of active pharmaceutical ingredients (API), significant European API producer, delivering products to companies worldwide

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Digital Content

Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA

Details:

PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.

Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: PB006

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Sandoz B2B

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2022

Polpharma Company Banner

CPhI Worldwide 2022

Booth # 80F30

envelop Contact Supplier

Polpharma

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A Polish CDMO of active pharmaceutical ingredients (API), significant European API producer, delivering products to companies worldwide

Contact Supplier

Contact Supplier

Digital Content

Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab

Details:

Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.

Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: PB006

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Sandoz B2B

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2022

Polpharma Company Banner

CPhI Worldwide 2022

Booth # 80F30

envelop Contact Supplier

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