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

NCT03595592 / Active, not recruitingPhase 3IIT

Atezolizumab, Pertuzumab and Trastuzumab With Chemotherapy as Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo)

n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.

Start Date07 Sep 2018

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

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]

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

INTRODUCTIONBiological 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.METHODSWe 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.RESULTSOf 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.CONCLUSIONOur 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.CLINICALTRIALSGOV REGISTRATIONNCT03892655.

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

AIMBreast 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.METHODSPubMed, 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.RESULTSWe 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.CONCLUSIONThere 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.

01 Feb 2022·Expert Opinion on Biological TherapyQ3 · MEDICINE

Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

Q3 · MEDICINE

Article

Author: Prakash Sadasivappa, Kirthi ; Vats, Bhavesh ; Ghosh, Ranendu ; Bera, Arnab ; Subbarao, Malini ; Goyal, Parag ; Parambath, Anusha Valiya ; Jadav, Rahul Singh ; Ullanat, Rajesh ; Babu, Moram Narendra ; Nair, Arya M. ; Honnappa, Chethan Gejjalagere ; Patnaik, Uma Sankar ; Sarkar, Anindya ; Mathew, Zacharia ; Singh, Ankita ; Kabadi, Pradeep

BACKGROUNDMYL-1401O; trastuzumab-dkst (Ogivri™; Mylan Inc.) is a biosimilar to the trastuzumab reference product (Herceptin®; Genentech, USA). Assessment of physicochemical stability and biological activity for the non-reconstituted, reconstituted, and infused solution over an extended, clinically relevant duration is critical for ensuring optimal patient outcomes and health resource utilization.METHODSThe physicochemical and biological stability of MYL-1401O was assessed in non-reconstituted vials stored at 25 °C ± 2 °C/60% ± 5% relative humidity (RH) for 6 months, reconstituted 21 mg/mL solution in vials stored at 2 °C to 8 °C for 10 days, and diluted in 0.9% saline-containing infusion bags at 0.3 mg/mL and 4.0 mg/mL stored for 77 days at 2 °C to 8 °C, plus an additional 2 days at 25 °C ± 2 °C/60% ± 5% RH.RESULTSAt all storage conditions tested, MYL-1401O was physicochemically and biologically stable for extended duration and under various temperature and humidity conditions.CONCLUSIONSMYL-1401O retained its physicochemical and biological stability under different storage conditions, which supports advanced preparation of MYL-1401O, better efficiency, less wastage, and cost-savings for better patient management.

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

21 May 2024

·www.prnewswire.com

Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S. Ophthalmology Market

BRIDGEWATER, N.J. and BENGALURU, India, May 21, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept). Continue Reading YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea®. The FDA approval of YESAFILI as the first interchangeable biological product to Eylea is a significant milestone. Post this The approval of YESAFILI marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: "The FDA approval of YESAFILI (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE®, the first biosimilar Trastuzumab, OGIVRI®, and the first biosimilar Pegfilgrastim, FULPHILA®, to patients in the United States." Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd , said: "Biosimilars are crucial for making healthcare more affordable and accessible. YESAFILI will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars." There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States.1 In the U.S., sales of aflibercept were approximately $5.89 billion in 2023.2 Biocon Biologics is a leading global company offering a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. It has achieved several "firsts" in the industry including the first to receive approval in the United States of a biosimilar trastuzumab (OGIVRI®, trastuzumab-dkst) and a biosimilar pegfilgrastim (FULPHILA®, pegfilgrastim-jmdb). Serving over 5.5M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the United States and six in Canada, with a robust pipeline of 20 biosimilar assets spanning multiple therapy areas. 1 Rein DB, Wittenborn JS, Burke-Conte Z, Gulia R, Robalik T, Ehrlich JR, Lundeen EA, Flaxman AD. Prevalence of Age-Related Macular Degeneration in the United States in 2019. JAMA Ophthalmology. Published Online: November 3, 2022 at: . Accessed April 29, 2024. 2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024. * An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. About YESAFILI: The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea®. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) WARNINGS AND PRECAUTIONS: YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept. Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. Please refer to full Prescribing Information for YESAFILI for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or . About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It 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. BBL has integrated the acquired global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on 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: ; Follow-us on Twitter: @bioconlimited for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. YESAFILI™ is a trademark of a Biosimilars Newco Limited, a Biocon Biologics Ltd. company. OGIVRI® and FULPHILA® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Ltd. company. All other trademarks, registered or unregistered, are the property of their respective owners. SOURCE Biocon Biologics Ltd.

Drug ApprovalPhase 3AcquisitionClinical ResultBiosimilar

09 Feb 2024

·www.prnewswire.com

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia. Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia. Trastuzumab is a biosimilar of Herceptin® and Bevacizumab is a biosimilar of Avastin®3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers. The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024. Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd, said: "Following the recent establishment of our strategic partnership with Sandoz in Japan, our agreement with Sandoz in Australia marks another important milestone of our global partnership and growth strategy. This relationship is also a crucial step for patients in Australia, ensuring continued access to high-quality, affordable biosimilar medicines used in oncology." 1 IQVIA MAT 2023 2 IQVIA MAT 2023 3 Australian Government, Department of health; Pharmaceutical Benefits Scheme – Biosimilar Bevacizumab. Accessed 24/1/2024 from OGIVRI® and ABEVMY® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. All other trademarks, registered or unregistered, are the property of their respective owners. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It 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. BBL has acquired the global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., EU, Australia, Canada, Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on Twitter: @BioconBiologics 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: ; Follow us on Twitter: @bioconlimited for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd.

License out/inAcquisitionImmunotherapyBiosimilar

18 Dec 2023

·www.prnewswire.com

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries

10+ Emerging Markets, Japan & ANZ Transition in Final Phase DUBAI, UAE, Dec. 18, 2023 /PRNewswire/ -- Biocon Biologics, a unique, fully integrated, global biosimilars company with a rich portfolio of insulins and monoclonal antibodies, has successfully concluded the integration of the acquired Viatris biosimilars business with the transition of 10+ Emerging Markets and Japan, Australia and New Zealand in the final phase. Continue Reading PFA the banner image (PRNewsfoto/Biocon Biologics Ltd) All Viatris' biosimilars brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim), Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine) and Kirsty® (bAspart) are now part of Biocon Biologics' commercial franchise in Advanced Markets and 80+ Emerging Markets. Most of these products have been developed by Biocon Biologics and are being manufactured at its world-class facilities in India and Malaysia. Biocon Biologics will now have a strong commercial footprint across ~120 countries with a direct presence in the U.S., Canada, Europe and 9 key Emerging Market countries of India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines. "I am very proud and excited that we have successfully completed the integration of the acquired business across 120 countries. The conclusion of this final wave of transition is a significant milestone and marks the beginning of Biocon Biologics' transformation to a fully integrated global company. I congratulate and thank the entire Biocon Biologics team – colleagues, advisors, and partners. This seamless transition, achieved ahead of schedule, is an outcome of relentless focus, untiring efforts and an unwavering commitment to patients and business continuity." - Shreehas Tambe, CEO & Managing Director. "This milestone presents a unique opportunity for our teams to take Brand Biocon Biologics directly to many markets. This self-led business model will take us closer to the patients, MoHs, prescribers and payers. It will allow us to expand affordable access to larger patient pools and generate significant savings for healthcare systems in these emerging markets, thus enabling equitable access to high quality biosimilars." - Susheel Umesh, Chief Commercial Officer - Emerging Markets. Biocon Biologics has made several key leadership appointments, built new capabilities and infrastructure from the ground up and set up dedicated teams to address the growing needs of patients and customers through self-led and partner or distributor-led commercial models to ensure business continuity for patients, prescribers, partners, and healthcare systems. Website: ; Twitter: @BioconBiologics; LinkedIn: Biocon Biologics SOURCE Biocon Biologics Ltd

AcquisitionExecutive ChangeDrug Approval

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Early Stage Breast Carcinoma	EU	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	NO	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	IS	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Early Stage Breast Carcinoma	LI	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	EU	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	LI	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	IS	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Hormone receptor positive breast cancer	NO	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	LI	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	IS	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	NO	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic Gastric Carcinoma	EU	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	IS	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	NO	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breast	EU	Biosimilar Collaborations Ireland Ltd.	12 Dec 2018
HER2 positive Gastrooesophageal junction cancer	AU	Alphapharm Pty Ltd.	11 Dec 2018
HER2 Positive Stomach Adenocarcinoma	AU	Alphapharm Pty Ltd.	11 Dec 2018
HER2 Positive Breast Cancer	US	Mylan Pharmaceuticals, Inc.	01 Dec 2017
HER2 positive Gastroesophageal Junction Adenocarcinoma	US	Mylan Pharmaceuticals, Inc.	01 Dec 2017
HER2-positive gastric cancer	US	Mylan Pharmaceuticals, Inc.	01 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 3	IN	Biocon Ltd.	-
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Preclinical	RU	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Preclinical	RO	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Preclinical	RS	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	CL	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	UA	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	HU	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	SK	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	LV	Mylan, Inc.	01 Jul 2012
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Discovery	IN	Mylan, Inc.	01 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Early Stage Breast Carcinoma Neoadjuvant	136	Trastuzumab-Ogivri	(xrwewamqou) = tpjpbedxfe vetlcrjijq (gukrgbjblt )	Negative	11 Jun 2022
				Trastuzumab	(xrwewamqou) = bvafwbsvbe vetlcrjijq (gukrgbjblt )
NCT02472964 (HERITAGE, Pubmed \| Breast Cancer Res)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast	500	trastuzumab-dkst	(ofpelmnzlp) = bhgebdiuyc kkfprezlgc (pwfvhwyzjt ) View more	Positive	14 Jun 2021
				trastuzumab	(ofpelmnzlp) = isvshsprlx kkfprezlgc (pwfvhwyzjt ) View more
NCT02472964 (ASCO2019) Manual	Phase 3	HER2 Positive Breast Cancer First line HER2 Positive	500	taxane+trastuzumab-dkst	(rejspafiuz) = oiqujxkxni zectzydzec (qofybsggpw ) View more	Similar	02 Jun 2019
				taxane+trastuzumab	(rejspafiuz) = tyvqlscphn zectzydzec (qofybsggpw ) View more
NCT02472964 (Heritage, ASCO2018)	Phase 3	Breast Cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast First line	500	Trastuzumab-dkst	(lgpzkclrqw) = qfldvwpmiv zqqveqjnzm (yrxdpgjaws ) View more	Positive	01 Jun 2018
				Trastuzumab	(lgpzkclrqw) = fxtpndbqtn zqqveqjnzm (yrxdpgjaws ) View more
NCT02472964 (HERITAGE, Pubmed \| J Coll Physicians Surg Pak) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2 Positive	458	taxane+trastuzumab biosimilar	(ghvjphhdre) = rvntfcpvgd waimmxkbdf (fobnbqmpay, 63.62 - 75.51) View more	Similar	03 Jan 2017
				taxane+Trastuzumab	(ghvjphhdre) = jobrfctaxq waimmxkbdf (fobnbqmpay, 57.81 - 70.26) View more

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