Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD
Details : 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 Ulcerative Colitis.
Brand Name : PB016
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 21, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab-sztn
Therapeutic Area : Neurology
Study Phase : Approved
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 scleros...
Brand Name : Tyruko
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 25, 2023
Lead Product(s) : Natalizumab-sztn
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : RVU120
Therapeutic Area : Oncology
Study Phase : Preclinical
Sponsor : Ryvu Therapeutics
Deal Size : $1.0 million
Deal Type : Agreement
Details : 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.
Brand Name : RVU120
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 06, 2023
Lead Product(s) : RVU120
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Sponsor : Ryvu Therapeutics
Deal Size : $1.0 million
Deal Type : Agreement
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 se...
Brand Name : Cimerli
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 03, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved
Recipient : Coherus Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 re...
Brand Name : Cimerli
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 02, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Recipient : Coherus Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 29, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
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 accumul...
Brand Name : PB006
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 25, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : PKL-021
Therapeutic Area : Neurology
Study Phase : Preclinical
Sponsor : Pikralida biopharmaceutical
Deal Size : Undisclosed
Deal Type : Partnership
Polpharma Partners with Pikralida Biopharmaceutical Start-Up
Details : 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.
Brand Name : PKL-021
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 19, 2022
Lead Product(s) : PKL-021
Therapeutic Area : Neurology
Highest Development Status : Preclinical
Sponsor : Pikralida biopharmaceutical
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : PB006
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 14, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
MHRA’s Authorization for BIOEQ’s Biosimilar in the United Kingdom
Details : 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
Brand Name : Cimerli
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 06, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.