Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC
Details : EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Brand Name : EG12014
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 22, 2023
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Study Phase : Phase III
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Sandoz Receives Positive CHMP Opinion for Breast and Gastric Cancer Biosimilar Trastuzumab
Details : EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Brand Name : EG12014
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 18, 2023
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pertuzumab
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : EG1206A (pertuzumab) targets the extracellular dimerization domain (Subdomain II) of the HER2 and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3 and HER4.
Brand Name : EG1206A
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 01, 2023
Lead Product(s) : Pertuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Study Phase : Phase III
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Sandoz Submits Biologics License Application for Proposed Biosimilar Trastuzumab to US FDA
Details : Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers. Sandoz is seeking approval for the same indications as the reference medicine.
Brand Name : EGI014A1
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 20, 2021
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar
Details : The purpose of the trial was to demonstrate the therapeutic equivalence in terms of efficacy between EG12014 to Herceptin®, and to compare the safety, immunogenicity and PK between the two trastuzumab products.
Brand Name : EG12014
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 23, 2021
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