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 Ltd.)

100 Translational Medicine associated with Trastuzumab-DKST(Biocon Ltd.)

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

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

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 ; Magaton, Érida ; Araújo, Márcia ; Fuzita, William ; Brito, Natália ; 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 Ltd.)

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

13 Aug 2024

·pharma.economictimes.indiatimes.com

Biocon arm's growth formula: US rollouts & debt reduction

Mumbai: Biocon Biologics , the biosimilar unit of Biocon , said it expects to launch six biosimilar products in the US, and is prioritising debt reduction to spur growth and lift margins. "Six product launches are scheduled in the next two years, subject to USFDA approvals ," Shreehas Tambe, chief executive and managing director, told ET in an interview. He added that the company is also exploring ways to reduce finance costs by optimising debt repayment timelines and interest rates. Tambe said Biocon Biologics has paid $175 million so far out of $335 million due to Viatris for the acquisition of biosimilar aflibercept. Biocon Biologics acquired Viatris' biosimilar business for $3.33 billion in November 2023. "The $335 million, made up of two components, $175 million we have to make for aflibercept and $160 million is deferred payment," Tambe said. "The $175 million we have already paid down, and that has come through the accruals that we had from the Eris Lifesciences deal and internal accruals . The balance of $160 million, we are comfortably able to make that payment," Tambe added. The company has outstanding debt of about $1.2 billion as of June 30. The company has repaid debt of $250 million. Biocon Biologics is Biocon's only unit to record revenue growth in the June quarter. Revenue at Biocon Biologics, which comprises 61 per cent of the parent's revenue, rose 3 per cent from a year earlier to ₹2,083 crore in Q1FY25. The company said on a like-to-like basis, the biosimilar business grew 11 per cent in the quarter, led by market share gains for biosimilars such as Ogivri (anti-cancer), Fulphila(anti-cancer), and Semglee (insulin glargine). Total revenue in the other two units-generics and API business--fell 6 per cent YoY to ₹659 crore in the June quarter. Research services business declined 2 per cent to ₹790 crore. Tambe said Biocon Biologics has expeditiously addressed Form 483 observations raised by USFDA in its July inspection through a comprehensive Corrective and Preventive Action (CAPA) plan. The company underwent a US FDA inspection of its manufacturing facilities for combined current good manufacturing practices (cGMP) and pre-licensing inspection (PLI) for five monoclonal antibody products. According to the company, the observations are procedural in nature and does not expect the current supply of its products. By Viswanath Pilla ,

Acquisition

100 Deals associated with Trastuzumab-DKST(Biocon Ltd.)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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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 breast cancer	European Union	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic breast cancer	Iceland	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic breast cancer	Liechtenstein	Biocon Biologics Ireland Ltd.	12 Dec 2018
Metastatic 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

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	bbizaxhoro(pfvrorxvyf) = pvahkbsdar confrejszi (ujwbuylqkn )	Negative	11 Jun 2022
				Trastuzumab	bbizaxhoro(pfvrorxvyf) = xjhabmlvgz confrejszi (ujwbuylqkn )
NCT02472964 (HERITAGE, Pubmed \| Breast Cancer Res Treat)	Phase 3	HER2 Positive Breast Cancer HER2-positive	-	trastuzumab-dkst	weaommhxbn(hsvstgcxtl) = ojxsfjayua dghhswtqvs (eovxqsccpu ) View more	Positive	01 Jul 2021
				trastuzumab	weaommhxbn(hsvstgcxtl) = szqlxxrmxg dghhswtqvs (eovxqsccpu ) View more
NCT02472964 (ASCO 12019 \| ASCO 22019) Manual	Phase 3	HER2 Positive Breast Cancer First line HER2 Positive	500	taxane+trastuzumab-dkst	ldjhqrpdir(khscwqikbs) = fhfulqguef zmmbirqsys (vxbezwvlqa ) View more	Similar	02 Jun 2019
				taxane+trastuzumab	ldjhqrpdir(khscwqikbs) = bwefoectzs zmmbirqsys (vxbezwvlqa ) View more
NCT02472964 (HERITAGE, CTgov)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast	500	Trastuzumab+Paclitaxel+Docetaxel	mgwrnslwtn = syvmlmfgld odcvygvhfd (ssndowcddo, xikjyrygwp - uamfypxayk) 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	qmgrvwqnwl(unqxvwrsge) = kdsxyqjzjc hpznmgrzte (ljpfvbujsx ) View more	Positive	01 Jun 2018
				Trastuzumab	qmgrvwqnwl(unqxvwrsge) = dqwtwwtmsq hpznmgrzte (ljpfvbujsx ) 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	vryanzweum(ezuxibqdga) = fueunbqxfm zweygtlagg (usrxwnkrea, 63.62 - 75.51) View more	Similar	03 Jan 2017
				taxane+Trastuzumab	vryanzweum(ezuxibqdga) = oaurdmngwt zweygtlagg (usrxwnkrea, 57.81 - 70.26) View more

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