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Which Will Market the First Chinese-produced Trastuzumab Biosimilar: Sunshine Guojian or Henlius? PharmaSources/Dopine
June 15, 2020
HER2-positive breast cancer has a high degree of malignancy and fast progression. Trastuzumab is the standard first-line regimen for adjuvant, neoadjuvant and metastatic cancer treatment of HER2-positive breast cancer.
Sandoz seeks EMA approval for EirGenix’s trastuzumab biosimilar Pharmaceutical-Business-Review
December 24, 2021
Trastuzumab is a monoclonal antibody intended to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast and metastatic gastric cancers.
Byondis Announces Positive Topline Results of Pivotal Phase III TULIP® Study in Patients with HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer b3cnewswire
June 09, 2021
Byondis B.V. today announced positive topline results from the Phase III TULIP® study, a multi-center, open-label, randomized clinical trial.
Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar prnasia
March 25, 2021
In a press conference today, EirGenix, Inc. announced that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint.
UK grants marketing authorisation to “landmark” breast cancer therapy europeanpharmaceuticalreview
February 23, 2021
Seagen’s Tukysa® (tucatinib) was approved in the UK as part of a combination regimen for the treatment of adults with locally advanced or metastatic HER2-positive breast cancer.
Biocon Biologics to offer its Oncology Biosimilars through Cancer Access Partnership in over 30 countries expresspharma
February 05, 2021
Biocon has signed an agreement with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP).
FDA Approves Pertuzumab, Trastuzumab, Hyaluronidase-zzxf Combination americanpharmaceuticalreview
July 01, 2020
The Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO, Genentech) for subcutaneous injection.
Biocon Biologics receives EU GMP Certification for multiple Biosimilars manufacturing facilities in expresspharma
May 20, 2020
These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets.
Seattle Genetics gets approval of TUKYSA in Switzerland for metastatic HER2-positive breast cancer pharmaceutical-business-review
May 15, 2020
Seattle Genetics announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast
Samsung Bioepis, Merck Launch Trastuzumab Biosimilar americanpharmaceuticalreview
April 16, 2020
Samsung Bioepis announced ONTRUZANT® (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN® (trastuzumab) for the treatment of ...

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