Sigrima (pertuzumab biosimilar) / Zydus Lifesci, Dr. Reddy’s - LARVOL DELTA

Zydus Lifscience Gets CDSCO Panel Nod To Study AntiCancer Drug Pertuzumab (Medical Dialogues) - "Zydus Lifsciences has got approval from the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) for a phase IV study to evaluate the safety of Pertuzumab (Sigrima, Zydus Lifesciences Limited) in patients with HER2-positive metastatic and early breast cancer...After detailed deliberation, the committee recommended the approval to conduct the Phase IV study with following changes in the protocol: The number of cycles to be increased for the patients who are responding to the treatment of 6 cycles in adjuvant and metastatic cancer settings at least for one year; The sample size should be increased considering the different settings of treatment for metastatic and early breast cancer, and the number of patients in each cancer setting should be proportionate; PI should be medical oncologist....In line with the above, the expert panel stated that the firm should submit revised protocol to CDSCO for further evaluation."

Clinical protocol • New P4 trial • HER2 Positive Breast Cancer

Zydus Barred From Selling Cancer Drug Sigrima As Delhi HC Restores Injunction In Favour Of Roche (Medical Dialogues) - "Upholding the patent rights of Swiss pharmaceutical giant F-Hoffmann-La Roche AG, the Delhi High Court has once again reinstated an interim injunction issued by a singlejudge against Zydus Lifesciences, preventing the drug maker from manufacturing, selling, or marketing its biosimilar drug 'Sigrima', which is allegedly similar to Roche's breast cancer drug 'Perjeta'....In light of this, the judge scheduled the next hearing for December 2, 2024. Until that time, the interim order issued on July 9, 2024, which restrains Zydus from marketing or selling its biosimilar drug Sigrima, will remain in effect, Bansal added."

Patent • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

High Court refuses interim injunction against Zydus' breast cancer drug (Pharmabiz) - "In a setback to Swiss multinational pharma company F-Hoffmann-La Roche, the Delhi High Court has dismissed an application filed by the company seeking injunction against Zydus Lifesciences Ltd's breast cancer drug Sigrima, a biosimilar of Pertuzumab...Roche alleged that Zydus has infringed two of its patents for its HER2 positive breast cancer drug Perjeta through its biosimilar product...The Court observed that Roche needed to establish that Zydus' product is likely to or is actually infringing their suit patents, through 'claim construction' and 'claim mapping', which is to detail the patents and their scope in order to establish that the generic product may infringe the patent protection....Roche claims that it has two patents related to the product, one which was granted on November, 2023 and valid till April 15, 2034, and another granted on September, 2015 and expected to expire on October 19, 2025."

Patent • Patent expiry • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Randomized, Double-Blind, Phase III Study in India for Comparing Efficacy, Safety, and PK of ZRC-3277 (Pertuzumab Biosimilar) With Perjeta® in Patients With HER2-Positive Metastatic Breast Cancer. (PubMed, Clin Breast Cancer) - "Efficacy, PK, immunogenicity, and safety profiles of ZRC-3277 was found to be similar to those of Perjeta®."

Clinical • Journal • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) (clinicaltrials.gov) - P3 | N=268 | Completed | Sponsor: Zydus Lifesciences Limited | Not yet recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Sep 2023 | Trial primary completion date: Jul 2024 ➔ Sep 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Zydus Lifesciences: Zydus barred from selling cancer biosimilar, for now (Firstwordpharma Press Release) - "The Delhi High Court in India has issued an interim injunction, preventing Zydus Lifesciences from selling its breast cancer drug Sigrima, a biosimilar of Roche's Perjeta (pertuzumab), following a patent infringement lawsuit filed by the Swiss pharma, reported The Economic Times; Roche had sought injunctive relief against the sale and distribution of Sigrima and Dr Reddy's Womab, arguing that they infringe its patents numbered IN 268632 and IN 464646."

Patent • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A randomized, double-blind, phase III study in India for comparing efficacy, safety, and PK of ZRC-3277 (pertuzumab biosimilar) with Perjeta in patients with HER2-positive metastatic breast cancer (Clin Breast Cancer) - P3 | N=268 | NCT05283837 | Sponsor: Zydus Lifesciences Limited | In the mITT population, 104 (87.39%) and 114 (91.94%) participants achieved the ORR in the ZRC-3277 and Perjeta groups, respectively. For predefined -15% non-inferiority margin, obtained two-sided 95% CIs (-12.19%, 3.11%) for the difference in ORR (-4.55%) between the two groups demonstrated the non-inferiority of ZRC-3277 to Perjeta. PK, immunogenicity, and safety were not significantly different between the two groups."

P3 data • HER2 Positive Breast Cancer

Zydus Life Science’s Anticancer Drug Pertuzumab Gets CDSCO Panel Nod For Additional Indication Of Early Breast Cancer (Medical Dialogues) - "The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Zydus Life Science's Pertuzumab 30 mg/mL concentrate solution for infusion for the additional indication of early breast cancer. However, this approval is subject to the condition that the firm conduct a Phase IV study of the anticancer drug Pertuzumab....This came after Zydus Life Sciences presented the proposal for approval of additional indications of early breast cancer for the approved similar biologic Pertuzumab 30 mg/mL concentrate solution for infusion (rDNA origin) by way of extrapolation with a waiver of a local clinical trial....Accordingly, the expert panel suggested to the firm that the protocol to conduct the Phase IV study be submitted to CDSCO within three months of the grant of permission for the proposed additional indication."

Approval • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Zydus Life, Dr Reddy's partner to co-market Pertuzumab biosimilar for breast cancer treatment (CNBC-TV18) - "Generic drugmaker Zydus Lifesciences Ltd on Friday (June 28) said it has entered into a licensing agreement with Dr Reddy’s Laboratories to co-market the Pertuzumab biosimilar, a critical treatment for HER2 positive breast cancer, in India....Under the terms of the agreement, Zydus will market the product under the brand name Sigrima, while Dr Reddy will market it as Womab. Under the terms of this agreement, Dr Reddy's will receive semi-exclusive rights from Zydus to co-market the product in India. Zydus will receive upfront licensing income and is eligible to receive milestone income based on the achievement of pre-defined milestones."

Licensing / partnership • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A randomized, double-blind, phase III study in India to evaluate efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) in comparison with Perjeta® (pertuzumab) in patients with HER2-positive metastatic breast cancer (EBCC 2024) - "Background: Pertuzumab in combination with trastuzumab and docetaxel is a standard-of-care treatment for HER2-positive metastatic breast cancer (MBC). Biosimilarity was observed between ZRC-3277 and the Perjeta® in terms of efficacy. No significant difference was observed in PK, immunogenicity, and safety. Hence ZRC-3277 will be a useful cost-effective alternative for treating HER2-positive MBC in India."

Clinical • Late-breaking abstract • Metastases • P3 data • PK/PD data • Alopecia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • HER-2

Roche requests DCGI to probe critical gaps in the clinical trial of its breast cancer drug Perjeta conducted by Zydus (Pharmabiz) - "Terming it a matter of 'patient safety', Roche has requested the Drugs Controller General of India (DCGI), the country’s regulatory agency, to inquire into the alleged critical gaps in the clinical trial conducted by Zydus of a drug originally developed by Roche. In the last couple of months, there were media reports where Swiss giant Roche had raised questions that Ahmedabad-based Zydus may have flouted rules while conducting its clinical trial for biosimilar pertuzumab. The reports indicated that the reference drug used by Zydus in the starting phase of the clinical trial was procured from unauthorized sources (not an appointed/authorized distributor of Roche India or any other Roche Affiliate), and hence, might be of 'questionable quality', 'compromised' or 'spurious'."

Clinical • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Swiss and Indian Pharma Giants Locked in Big War; Land at DCGI Door Over Breast Cancer Drug (News18 India) - "Swiss pharmaceutical firm Roche has sounded alarm against clinical trials conducted by Zydus Lifesciences on its biologic drug Perjeta, a widely-used breast cancer treatment. The Swiss company has filed a complaint against the Indian drug maker over alleged critical gaps in the clinical trial of a drug originally developed by Roche. Roche, a global biotech giant, claims that the drug used by Zydus in the starting phase of clinical trials has not been procured from them and, hence, might be of 'questionable quality', 'compromised' or 'spurious'....On November 24, Roche wrote a letter to the Drug Controller General of India (DCGI), urging the regulator to intervene and probe the issue. On February 7, it reiterated the request....While the comparator agent or drug to be used in comparison in the clinical trial is Roche’s brand Perjeta, the intervention drug being tested is Zydus’s drug labelled as ZRC-3277."

Clinical • Breast Cancer • Oncology • Solid Tumor