Herceptin is the brand name for trastuzumab, a HER2/neu receptor antagonist used in HER2-overexpressing cancers. It is indicated for breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA first approved Herceptin on September 25, 1998.
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
The large molecule drug substance CDMO market is expected to grow at approximately 9% CAGR through 2031, driven by rising demand for biologics and biosimilars, streamlined regulatory approval pathways, and increasing FDA and EMA approvals for biologic therapies.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05765357 |
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers |
COMPLETED | PHASE1 |
| NCT05301530 |
Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients. |
COMPLETED | PHASE1 |
| NCT05301010 |
Clinical Trial to Assess Efficacy and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients |
COMPLETED | PHASE3 |
| NCT04905667 |
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ® |
COMPLETED | PHASE1 |
| NCT03989037 |
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer |
COMPLETED | PHASE3 |
| NCT03907800 |
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer |
UNKNOWN | PHASE2 |
| NCT03879577 |
Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT03433313 |
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer |
COMPLETED | PHASE3 |
| NCT03390608 |
Prognostic and Predictive Factors for Small Breast Tumors |
COMPLETED | |
| NCT03272477 |
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients |
COMPLETED | PHASE2 |
