2026-05-29
Shanghai Henlius Biotech
Henlius' Pertuzumab Approved in China, Solidifying Breast Cancer Strategy as the First China-US-EU Approved Chinese Trastuzumab-Pertuzumab Combination henlius.com ↗
2026-04-29
Organon and Co
European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe organon.com ↗
2026-04-29
Shanghai Henlius Biotech
European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe henlius.com ↗
2026-02-27
Shanghai Henlius Biotech
EMA CHMP Recommends EU Approval of Henlius’ Pertuzumab Biosimilar HLX11 henlius.com ↗
2025-11-17
Organon and Co
Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US organon.com ↗
2025-11-17
Shanghai Henlius Biotech
Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US henlius.com ↗
2025-05-13
Hoffmann-La Roche
Ten-year APHINITY data show Roche’s Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer roche.com ↗
2025-05-13
Chugai Pharmaceutical
Roche Announces New Ten-Year Data of Perjeta-Based Regimen for HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗
2025-05-12
Genentech, Inc.
Ten-Year APHINITY Data Show Genentech’s Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer gene.com ↗
2025-03-28
Organon and Co
European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗
2025-03-28
Shanghai Henlius Biotech
European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 henlius.com ↗
2025-02-02
Shanghai Henlius Biotech
US FDA Accepts Biologics License Application (BLA) for HLX11, Biosimilar Candidate of Perjeta® (pertuzumab) henlius.com ↗
2024-09-30
Organon and Co
Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗
2024-09-30
Shanghai Henlius Biotech
Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 henlius.com ↗
2023-09-25
Chugai Pharmaceutical
Chugai Obtains Regulatory Approval for Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer chugai-pharm.co.jp ↗
2022-09-29
Chugai Pharmaceutical
Chugai Files New Drug Application in Japan for Fixed-Dose Subcutaneous Combination of Pertuzumab and Trastuzumab for HER2-Positive Breast and Colorectal Cancer chugai-pharm.co.jp ↗
2022-07-14
Hoffmann-La Roche
Eight-year data from APHINITY study show Roche’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer roche.com ↗
2022-06-13
Organon and Co
Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates organon.com ↗
2022-03-28
Chugai Pharmaceutical
Chugai Obtains Regulatory Approval for Perjeta and Herceptin for Additional Indication of HER2-Positive Colorectal Cancer chugai-pharm.co.jp ↗
2020-12-23
Hoffmann-La Roche
European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer roche.com ↗
2020-12-23
Halozyme Therapeutics
Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
2020-11-13
Hoffmann-La Roche
CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer roche.com ↗
2020-11-13
Halozyme Therapeutics
Halozyme Announces CHMP Recommends EU Approval Of Roche's Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For HER2-Positive Breast Cancer halozyme.com ↗
2020-06-29
Hoffmann-La Roche
FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer roche.com ↗
2020-06-29
Genentech, Inc.
FDA Approves Genentech’s Phesgo (Fixed-Dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-Positive Breast Cancer gene.com ↗
2020-06-29
Halozyme Therapeutics
Halozyme Announces Roche Receives FDA Approval For Phesgo™ (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
2020-02-25
Hoffmann-La Roche
FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer roche.com ↗
2020-02-25
Halozyme Therapeutics
Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology halozyme.com ↗
2020-02-24
Genentech, Inc.
FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer gene.com ↗
2019-12-12
Hoffmann-La Roche
Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer roche.com ↗
2019-12-12
Halozyme Therapeutics
Data From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's ENHANZE® Drug Delivery Technology To Be Presented At San Antonio Breast Cancer Symposium halozyme.com ↗
2019-12-11
Hoffmann-La Roche
APHINITY six-year results strengthen evidence of clinical benefit with Roche’s Perjeta-based regimen roche.com ↗
2019-12-11
Genentech, Inc.
Genentech’s Fixed-dose Subcutaneous Combination of Perjeta and Herceptin Comparable to Intravenous Formulations in People With HER2-Positive Breast Cancer gene.com ↗
2019-09-13
Hoffmann-La Roche
Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer roche.com ↗
2019-09-13
Halozyme Therapeutics
Positive Results Announced From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's Enhanze® Drug Delivery Technology halozyme.com ↗
2019-09-12
Genentech, Inc.
Genentech’s Fixed Dose Subcutaneous Combination of Perjeta And Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer gene.com ↗
2018-10-10
Chugai Pharmaceutical
Anti-Cancer Agent “PERJETA ® ,” Approved for Additional Indication of “Neoadjuvant and Adjuvant Therapy for HER2-Positive Early Breast Cancer” chugai-pharm.co.jp ↗
2018-07-26
Halozyme Therapeutics
Phase 3 Study Of Subcutaneous Pertuzumab And Trastuzumab Initiated Using Halozyme's ENHANZE® Technology halozyme.com ↗
2018-06-01
Hoffmann-La Roche
European Commission approves Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence roche.com ↗
2018-04-27
Hoffmann-La Roche
CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence roche.com ↗
2017-12-21
Hoffmann-La Roche
FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer roche.com ↗
2017-12-20
Genentech, Inc.
FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer gene.com ↗
2017-10-25
Chugai Pharmaceutical
Anti-Cancer Agent "Perjeta ® " Filed for Additional Indication of Adjuvant Therapy for HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗
2017-09-29
Hoffmann-La Roche
FDA grants Priority Review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer roche.com ↗
2017-09-28
Genentech, Inc.
FDA Grants Priority Review for Genentech’s Perjeta® (Pertuzumab) for Adjuvant Treatment of HER2-Positive Early Breast Cancer gene.com ↗
2017-06-05
Hoffmann-La Roche
APHINITY study shows Roche’s Perjeta-based regimen reduced the risk of invasive cancer returning compared to Herceptin and chemotherapy in HER2-positive early breast cancer roche.com ↗
2017-06-05
Genentech, Inc.
APHINITY Study Shows Genentech’s Perjeta-Based Regimen Reduced the Risk of Invasive Cancer Returning Compared to Herceptin and Chemotherapy in HER2-Positive Early Breast Cancer gene.com ↗
2017-03-02
Hoffmann-La Roche
Phase III APHINITY study shows Roche’s Perjeta® regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin® and chemotherapy roche.com ↗
2017-03-01
Genentech, Inc.
Phase III APHINITY Study Shows Genentech’s Perjeta® Regimen Helped People with an Aggressive Type of Early Breast Cancer Live Longer without their Disease Returning Compared to Herceptin® and Chemotherapy gene.com ↗
2015-05-31
Genentech, Inc.
Genentech’s Perjeta Regimen Helped People with HER2-Positive Early Breast Cancer Live Longer without Their Disease Returning or Getting Worse Compared to Herceptin and Chemotherapy gene.com ↗
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