This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.

Start Date27 Feb 2019

Sponsor / Collaborator

Roche Pharma AG

NCT02594761

/ CompletedPhase 1

Pharmacokinetic Study Comparing Hercules, EU-approved Herceptin® and US-Licensed Herceptin® Administered as a Single Intravenous Infusion to Healthy Male Volunteers

The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8 mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®. Secondary objectives included further pharmacokinetic assessment of similarity of Hercules, EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of safety (including immunogenicity) and local tolerance.

Start Date01 Aug 2013

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

[+1]

NCT02472964

/ CompletedPhase 3

A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study of the Efficacy and Safety of Hercules Plus Taxane Versus Herceptin® Plus Taxane as First Line Therapy in Patients With HER2-Positive Metastatic Breast Cancer

A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane as first line therapy in patients with HER2-positive metastatic breast cancer.

Start Date01 Jul 2012

Sponsor / Collaborator

Mylan NV

[+1]

100 Clinical Results associated with Trastuzumab-DKST(Biocon)

100 Translational Medicine associated with Trastuzumab-DKST(Biocon)

100 Patents (Medical) associated with Trastuzumab-DKST(Biocon)

Literatures (Medical) associated with Trastuzumab-DKST(Biocon)

01 Mar 2025·BIODRUGS

An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies

Article

Author: Shrivastava, Anuj ; Patil, Sanjeet S ; Rathore, Anurag S ; Shah, Rohan

BACKGROUND:

With the expiration of patents for multiple biotherapeutics, biosimilars are gaining traction globally as cost-effective alternatives to the original products. Glycosylation, a critical quality attribute, makes glycosimilarity assessment pivotal for biosimilar development. Given the complexity of glycoanalytical profiles, assessing glycosimilarity is nontrivial.

OBJECTIVE:

This study proposes a Python-based automated tool for rapid estimation of glycosimilarity index (GI).

MATERIALS AND METHODS:

A comprehensive analytical glycosimilarity comparison of the trastuzumab originator product, Herclon (Roche), with five marketed biosimilars:Trasturel (Reliance Life Sciences), Canmab (Biocon), Vivitra (Zydus Ingenia), Hertraz (Mylan), and Biceltis (Cipla), has been performed. Similarly, a comparison between the bevacizumab originator product, Avastin (Roche), and its five biosimilars: Abevmy (Mylan), Krabeva (Biocon), Ivzumab (RPG LifeSciences), Bryxta (Zydus), and Advamab (Alkem Labs), is presented. Glycan profile has been assessed using liquid chromatography-fluorescence detection, and the data have been integrated using the XGBoost-machine learning algorithm to quantify glycan composition. The GI has been calculated by combining profile similarity and compositional similarity, estimated on the basis of the criticality and tolerance of each glycan.

RESULTS:

The tool enabled rapid GI estimation (< 1 min/sample) with reduced errors compared with Excel (> 10 min/sample). Biosimilars exhibited high GI with several exceeding 95%, while the lowest GI observed were 87.80% for trastuzumab and 92.39% for bevacizumab.

CONCLUSIONS:

The Python-based tool offers a high-throughput and a reliable platform for glycosimilarity assessment, outperforming traditional analysis. Minor variations in glycosylation patterns were observed among the biosimilars, suggesting a modest glycosimilarity variation (GI range between 80 and 100%). However, the limited number of innovator batches analyzed constrained the establishment of definitive tolerance limits. Future studies should focus on analyzing larger datasets to improve accuracy and define precise tolerance limits, enhancing the tool's reliability and its potential to accelerate biosimilar development.

01 Sep 2024·Oncology and Therapy

Real-World Study of Adjuvant Biosimilar Trastuzumab-dkst for HER2-Positive Breast Cancer Treatment in a Brazilian Population

Article

Author: França, Bruno ; Matias, Danielli ; Brito, Natália ; Fuzita, William ; Magaton, Érida ; Araújo, Márcia ; Pimentel, Sâmio ; Tavares, Monique ; Castilho, Vivienne ; Gagliato, Debora ; Rocha, Cláudio ; Aleixo, Sabina ; Cardoso, Ana Carolina ; Reinert, Tomás

INTRODUCTION:

Biological monoclonal antibodies play a pivotal role in cancer treatment, with biosimilars significantly enhancing their accessibility. In Brazil's ethnically diverse setting, real-world evidence is crucial for assessing the effectiveness and applicability of these therapies in routine clinical practice.

METHODS:

We performed a multicentric, observational, prospective real-world study on biosimilar trastuzumab-dkst for adjuvant treatment of early HER2-positive breast cancer in Brazilian patients. Data were collected using a case-report form.

RESULTS:

Of the 176 recruited, we present data from the first 59 patients (mean age 51.7 ± 12.9 years) who had completed treatment with trastuzumab-dkst. The mean time from diagnosis to the first adjuvant treatment with trastuzumab-dkst was 5.5 ± 2.7 months. Of the patients, 59% of patients achieved at least a 30-month follow-up. The 31.7-month invasive disease-free survival rate (IDFS) was 94.5% (95% CI 83.9-98.2%) and median IDFS was not achieved, since only three patients had invasive disease recurrence. The overall survival rate was 100% until the last assessment. The observed adverse events were similar to those presented by other studies using biosimilar or reference trastuzumab. Four serious adverse events (8.5%) were observed. A reduction in left ventricular ejection fraction of at least 10% was observed in 16.9% of participants. There was no treatment interruption, and three participants (5.1%) had their trastuzumab-dkst dose reduced.

CONCLUSION:

Our study reinforces the existing pivotal data, underscoring the real-world efficacy and safety of biosimilar trastuzumab-dkst in the adjuvant treatment for early HER2-positive breast cancer. The preliminary long-term effectiveness and safety data we present further validate trastuzumab-dkst's role as a cost-saving alternative in oncological care. These findings have important implications for improving patient access to crucial treatments and for the more efficient use of healthcare resources.

CLINICALTRIALS:

GOV REGISTRATION:

NCT03892655.

02 Nov 2022·Immunopharmacology and immunotoxicology

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis

Review

Author: Dong, Mei ; Liu, Tong ; Jin, Yao ; Liu, Duo

AIM:

Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

METHODS:

PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.

RESULTS:

We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.

CONCLUSION:

There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

News (Medical) associated with Trastuzumab-DKST(Biocon)

21 Nov 2025

·pharma.economictimes.indiatimes.com

Biocon in very unique position globally as a biosimilars leader: Kiran Mazumdar-Shaw

Mumbai: Biocon is entering a transformative phase in its journey as a global biosimilars leader driven by regulatory shifts in the US, strategic partnerships and a robust insulin and GLP-1 portfolio, executive chairperson Kiran Mazumdar-Shaw said. The company is uniquely positioned to accelerate growth, reduce financial burden and expand its footprint in the high-value biologics space, Shaw told ET in an exclusive interview. "We are in a sweet spot and a very unique position," Shaw said. "Nobody else has interchangeable insulins and insulin now is becoming a very big opportunity for Biocon Biologics because of the fact that the actual insulin companies are planning to focus on GLP-1s. We are taking that advantage globally." Biocon is the only company with interchangeable biosimilar insulin analogues like insulin glargine (Semglee) and insulin aspart (Kirsty) in the US market. According to Shaw, the company's acquisition of Viatris' global portfolio of biosimilars, often scrutinised for its debt impact, has strengthened Biocon 's position as one of the top five biosimilars companies globally. Biocon Biologics acquired Viatris' global biosimilars business in 2022 for $3.3 billion and has been trying to cut acquisition-related debt of $1.2 billion. "People focus too much on the acquisition debt and not enough on the fact that we have become a leading global biosimilars company," said Mazumdar-Shaw. Referring to the company's R&D priorities in new therapeutic areas such as GLP-1 analogues , Mazumdar-Shaw said: "We have done this successfully for insulins and for liraglutide and are confident that semaglutide will be quite straightforward for us." According to Shaw, the recent draft guidelines by the USFDA, which propose to waive off the requirement for phase-III clinical trials for certain biosimilars that demonstrate robust chemistry, manufacturing and controls (CMC) package, presents a significant opportunity for Biocon . The USFDA's new draft guidance eliminates the need for most comparative efficacy trials-the costliest and slowest step in biosimilar development. Instead, it will allow developers to rely on advanced analytical and functional testing to demonstrate similarity with reference biologics. The agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. "Once we get the first approval without phase-III trials, it will set the stage for more launches and significantly reduce our R&D costs." It will allow the company to do more for the same amount of R&D spend, creating a compelling advantage over competitors, according to Mazumdar-Shaw. Biocon has already delivered an array of biosimilars over the past 12-18 months, including ustekinumab (Yesintek, used to treat chronic autoimmune condition), aflibercept (Yesafili, used for treatment of certain eye conditions), insulin aspart (Kirsty), bevacizumab (Jobevne, a cancer drug), and recently denosumab (Bosaya and Aukelso indicated for osteoporosis and cancer-related bone). The company has also reached a settlement with Amgen for denosumab, enabling its upcoming US launch. With these approvals, Biocon is in the "acceleration" phase, having built a diversified portfolio that few competitors, including Sandoz, Amgen, Pfizer , Celltrion, or Samsung, can match in scale and vertical integration, said Mazumdar-Shaw. "We have a large basket of biosimilars now in the market and nobody else has this scale of products," she said. Biocon's cancer drugs Fulphila (pegfilgrastim) and Ogivri (trastuzumab) have over 25% US market share. "The kind of growth story we are creating is going to be exciting in the immediate five-year window and beyond," said Mazumdar-Shaw. "After 2030, there will be some very exciting products becoming big-ticket opportunities for companies like us, more cancer drugs PD-1s and many other products." The insulin and GLP-1 segments are emerging as high-growth adjacencies for Biocon. Shaw emphasised that the company's deep experience in insulin manufacturing and patient familiarity with Biocon devices provide a natural advantage in GLP-1 analogues , so introducing GLP-1 is seamless. By Rica Bhattacharyya ,

AcquisitionLicense out/inDrug Approval

10 Apr 2025

·pipelinereview.com

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly Twitter ): @BioconBiologics and LinkedIn : Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

Drug ApprovalImmunotherapy

09 Apr 2025

·www.pharmaindustrial-india.com

Biocon Biologics Announces USFDA Approval of JOBEVNE Biosimilar for Cancer Treatment

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd announced that the US Food and Drug Administration (US FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: "The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients." In the U.S., sales of bevacizumab were approximately USD 2.0 billion in 2023.

Drug ApprovalImmunotherapyBiosimilar

100 Deals associated with Trastuzumab-DKST(Biocon)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Stomach Cancer	Canada	BGP Pharma ULC	01 May 2019
Early Stage Breast Carcinoma	European Union	Biocon Biologics Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	Iceland	Biocon Biologics Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	Liechtenstein	Biocon Biologics Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	Norway	Biocon Biologics Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	European Union	Biocon Biologics Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	Iceland	Biocon Biologics Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	Liechtenstein	Biocon Biologics Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	Norway	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	European Union	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	Iceland	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	Liechtenstein	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	Norway	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	European Union	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Iceland	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Liechtenstein	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Norway	Biocon Biologics Ireland Ltd.	12 Dec 2018
HER2 positive Gastrooesophageal junction cancer	Australia	Alphapharm Pty Ltd.	11 Dec 2018
HER2 Positive Stomach Adenocarcinoma	Brazil	Libbs Farmacêutica Ltda.	18 Dec 2017
Metastatic breast cancer	Brazil	Libbs Farmacêutica Ltda.	18 Dec 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Early Stage Breast Carcinoma Neoadjuvant	136	Trastuzumab-Ogivri	tmsrdyckup(gsevrhlvxl) = ugoxshbjaa ogsqlanivh (obrqehrucs )	Negative	11 Jun 2022
				Trastuzumab	tmsrdyckup(gsevrhlvxl) = wiuvshkdrt ogsqlanivh (obrqehrucs )
NCT02472964 (HERITAGE, Pubmed \| Breast Cancer Res Treat)	Phase 3	HER2 Positive Breast Cancer HER2-positive	-	trastuzumab-dkst	jwwdmoflcf(gxpvkmbngu) = dzttsdyekv bnofxjgoqj (ilrxlnebvg ) View more	Positive	01 Jul 2021
				trastuzumab	jwwdmoflcf(gxpvkmbngu) = armeqpvqcc bnofxjgoqj (ilrxlnebvg ) View more
NCT02472964 (ASCO 12019 \| ASCO 22019) Manual	Phase 3	HER2 Positive Breast Cancer First line HER2 Positive	500	taxane+trastuzumab-dkst	pqmkfxjkaf(iwbnrgwbhj) = wcuprbauio rjhvuzzkcw (oymtpobrje ) View more	Similar	02 Jun 2019
				taxane+trastuzumab	pqmkfxjkaf(iwbnrgwbhj) = hjfoccgpfk rjhvuzzkcw (oymtpobrje ) View more
NCT02472964 (HERITAGE, CTgov)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast	500	Trastuzumab+Paclitaxel+Docetaxel	ddszakxbcr = hhsfnukywr bxczwlwtqt (itqopvmptk, yvqaksuwlm - ixodwtnklu) View more	-	30 Oct 2018
NCT02472964 (Heritage, ASCO2018)	Phase 3	Breast Cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast First line	500	Trastuzumab-dkst	zrltamhlcz(ijlujmupzl) = oxgufdvghd izxpkgncgm (jrqtpucmzo ) View more	Positive	01 Jun 2018
				Trastuzumab	zrltamhlcz(ijlujmupzl) = jqnvitwloh izxpkgncgm (jrqtpucmzo ) View more
NCT02472964 (HERITAGE, Pubmed \| J Coll Physicians Surg Pak \| JAMA) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2 Positive	458	taxane+trastuzumab biosimilar	uvnnuigvjh(ljszykraja) = qtzdoriefd ytbajknmjd (qvuchiexjb, 63.62 - 75.51) View more	Similar	03 Jan 2017
				taxane+Trastuzumab	uvnnuigvjh(ljszykraja) = bwmvyeolxe ytbajknmjd (qvuchiexjb, 57.81 - 70.26) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis