[{"orgOrder":0,"company":"Polpharma","sponsor":"MS Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bioeq, the Polpharma Biologics Group Joint Venture Company and MS Pharma Sign Exclusive Agreement for Ranibizumab in MENA","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Group Announces that Its Joint Venture Bioeq Has Submitted a Biologics License Application (BLA) For Biosimilar Ranibizumab to The U.S. Food and Drug Administration (FDA)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Coherus Biosciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Coherus\u2019 CIMERLI\u2122 (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis\u00ae for All Five Indications, with 12 Months of Interchangeability Exclusivity","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration (FDA) Approves FYB201\/CIMERLITM* (ranibizumab-eqrn), The First and Only Biosimilar Interchangeable with Lucentis\u00ae**","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysabri\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MHRA\u2019s Authorization for BIOEQ\u2019s Biosimilar in the United Kingdom","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Polpharma","sponsor":"Pikralida biopharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Polpharma Partners with Pikralida Biopharmaceutical Start-Up","therapeuticArea":"Neurology","highestDevelopmentStatus":"Preclinical","country":"POLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Preclinical"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Receives FDA Approval for Tyruko (natalizumab-sztn), First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Polpharma","sponsor":"Ryvu Therapeutics","pharmaFlowCategory":"D","amount":"$1.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ryvu Therapeutics Enters into Two Agreements with Zak\u0142ady Farmaceutyczne Polpharma S.A. in the Area of RVU120 Active Substance (API) Production for Phase II Clinical Trials","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"POLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics' Investigational Biosimilar Shows PK\/PD Comparability to Inflammatory Bowel Disease Blockbuster Entyvio\u00ae","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2024","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Polpharma
PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for the treatment of Ulcerative Colitis.
Tyruko (natalizumab-sztn) biosimilar 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.
RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors.
CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with serious retinal diseases.
The COLUMBUS-AMD study, published in highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI (ranibizumab) met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.
Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
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.
The partnership involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial.
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.
CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation