Jobevne (bevacizumab-nwgd) / Biocon, Sandoz - LARVOL DELTA

Biocon share price rises 4% on US FDA approval for cancer drug (TradingView) - "Biocon share price rose nearly 4 percent in the early trade on April 11 following the company's subsidiary received US Food and Drug Administration (USFDA) approval for a cancer drug. At 09:29am, Biocon was quoting at Rs 316.85, up Rs 11.65, or 3.82 percent, on the BSE."

Commercial • Cervical Cancer • Colorectal Cancer • Fallopian Tube Cancer • Glioblastoma • Lung Non-Squamous Non-Small Cell Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

The U.S. Food and Drug Administration (U.S. FDA) has approved Biocon Biologics’ Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. (The Hindu) - "The U.S. Food and Drug Administration (U.S. FDA) has approved Biocon Biologics’ Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use."

FDA approval • Cervical Cancer • Colorectal Cancer • Glioblastoma • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies. (PubMed, BioDrugs) - "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."

Journal

A multicenter, open-label, single-arm, phase IV study evaluating the safety of biosimilar bevacizumab in patients with solid tumors (ESMO Asia 2024) - "Conclusions Biosimilar bevacizumab was well tolerated when administered to patients with solid tumors treated as per the PI, and no significant safety concerns were observed. Overall, the nature of the reported AEs in this study is in line with the safety profile of bevacizumab."

Clinical • P4 data • Brain Cancer • CNS Tumor • Glioblastoma • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

Post-marketing study to evaluate the safety and efficacy of bevacizumab biosimilar in patients with advanced ovarian cancer (ESMO Asia 2024) - "Conclusions Among the OC efficacy population (n=99), overall response rate (ORR) and disease control rate (DCR) were reported as 46.5% and 74.7%, with no assessment for 18 patients (adjusted ORR=56.8%). ORR among PSR patients (n=43) was 65% and among PRR patients (n=18) was 33% (5 patients were frontline and 31 patients lacked platinum sensitivity assessment)."

Clinical • Metastases • P4 data • Oncology • Ovarian Cancer • Solid Tumor

EMA Approves Biocon Biologics' New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites (PRNewswire) - "Biocon Biologics Ltd...has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru. This approval will provide significant additional capacity to address patients' needs across markets in Europe....The Company also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility at Bengaluru and its insulin facility in Malaysia following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA."

European regulatory • Oncology • Solid Tumor

Value of Being the First Biosimilar Entrant (ISPOR 2024) - " We used IQVIA NSP data on monthly U.S. sales of 21 biosimilars and 7 reference biologics from Q3 2015 through Q1 2023 that comprised seven markets: bevacizumab, epoetin alfa, filgrastim, infliximab, pegfilgrastim, rituximab, and trastuzumab. Being the first biosimilar to market has an enduring advantage. Of the total biosimilar sales for a given market, the first entrant’s share is 27.0% higher than the second entrant’s. While the advantage is less by percentage than generic drugs, it may be larger by revenues given the size of biologics markets."

Biocon arm gets complete response letter from USFDA for Bevacizumab biosimilar licence application (CNBC-TV18) - "Global biopharmaceuticals company Biocon on Friday, February 9, said the United States Food and Drug Administration (USFDA) has issued a complete response letter (CRL) for its licence application for the cancer drug Bevacizumab. The US drug regulator has called for completion of a pre-approval inspection of its manufacturing facility, the company said in a stock exchange filing."

Complete response letter • Oncology

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab (PRNewswire) - "Biocon Biologics Ltd...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 million) and biosimilar Bevacizumab (market value of AUD$45 million) 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....The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024."

Licensing / partnership • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Glioblastoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim)...and Kirsty® (bAspart), will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Chemotherapy-Induced Neutropenia • CNS Tumor • Gastrointestinal Cancer • Oncology • Solid Tumor

Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin) in Patients with Non-squamous Non-small Cell Lung Cancer. (PubMed, Eur J Drug Metab Pharmacokinet) - P1, P3 | "PopPK analysis revealed no significant differences between pharmacokinetics of MYL-1402O and Avastin in patients with nsNSCLC. The developed PopPK model was considered robust, as it adequately described bevacizumab pharmacokinetics in healthy participants and nsNSCLC patients."

Journal • PK/PD data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Assessment of structural and functional similarity of biosimilar products: Bevacizumab as a case study. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "A comprehensive analytical and functional biosimilarity assessment has been performed to examine and compare innovator product of bevacizumab (Avastin-innovator product, Roche Products (India) Pvt Ltd) and six biosimilars that are being marketed in India (Abevmy from Mylan Pharmaceuticals Pvt Ltd, Bevazza from Lupin Ltd, Bryxta from Zydus Cadila, Krabeva from Biocon, Ivzumab from RPG Life Sciences Ltd, and Advamab from Alkem Laboratories Ltd)...The analysis of the analytical, functional and chemometric results revealed significant levels of similarity, with biosimilar4 being the sole exception. Despite being within product specifications, Biosimilar4 displayed significant deviations with respect to critical quality attributes, including a lower proportion of monomer content, a larger percentage of basic charge variant species, and a lower proportion of aglycosylated glycoform."

Journal • Breast Cancer • Oncology • Solid Tumor

Identification of a specific epigenetic signature in patients showing secondary hypertension upon anti-VEGF treatment from the GEICAM/2011-04 (BRECOL) study (SABCS 2019) - P=N/A; "METHODS Patients (n=113) from BRECOL study (NCT01733628) received bevacizumab in combination with oxaliplatin or irinotecan + fluoropyrimidines for metastatic colorectal cancer (n=49), and with paclitaxel or capecitabine for metastatic breast cancer (n=64). CONCLUSIONS High BP upon anti-angiogenic treatment is associated to specific DNA methylation profiles. We identified an epigenetic methylation signature putative predictive of secondary HTN to bevacizumab treatment in metastatic breast and colorectal cancer."

Clinical • HIF1A • KCNJ8

A bioequivalence study of proposed bevacizumab biosimilar, MYL-1402O (A) vs EU-Avastin (B) and US-Avastin (C). (ASCO 2017) - P1; "These results confirm bioequivalence of Myl-1402O vs. EU-Avastin and US-Avastin. All treatments were well tolerated and no significant safety issues emerged."

Clinical • Biosimilar • Oncology

Viatris and Biocon Biologics Launch Abevmy (Bevacizumab), Their Third Oncology Biosimilar, in Canada (Canada Newswire) - "Viatris Inc. and Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced today that Abevmy® (bevacizumab) is now available in Canada. Abevmy, co-developed by Viatris and Biocon Biologics, is a biosimilar to Roche's Avastin® (bevacizumab) and has been approved by Health Canada across four oncology indications...The approval of Abevmy was based on a comprehensive analytical, pre-clinical and clinical program. Abevmy is authorized for use in the following indications: Metastatic Colorectal Cancer (mCRC), Locally Advanced Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC), Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer, Malignant Glioma (WHO Grade IV) - Glioblastoma. The two formats approved and now available in Canada are: 100 mg/4 mL single-use vial and 400 mg/16 mL single-use vial."

Biosimilar launch • Colorectal Cancer • Fallopian Tube Cancer • Glioblastoma • Glioma • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=111 | Completed | Sponsor: Mylan Inc. | Active, not recruiting ➔ Completed

Trial completion

MYL-1402O: A Bevacizumab Biosimilar. (PubMed, Target Oncol) - "The tolerability, safety and immunogenicity profiles of MYL-1402O were consistent with those of reference bevacizumab. The role of reference bevacizumab in the management of solid cancers is well established and MYL-1402O provides an effective biosimilar alternative for patients requiring bevacizumab therapy."

Journal • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer. (PubMed, Ther Adv Med Oncol) - P3 | "Patients were randomly assigned (1:1) to receive MYL-1402O or bevacizumab with carboplatin-paclitaxel up to 18 weeks (6 cycles), followed by up to 24 weeks (8 cycles) of bevacizumab monotherapy. The incidence of neutralizing antibody post-baseline was lower with MYL-1402O (0.6%) than with bevacizumab (2.5%). These findings confirm therapeutic equivalence of MYL-1402O to bevacizumab, providing opportunities for improving access to bevacizumab."

Clinical • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

[VIRTUAL] Phase III confirmatory efficacy and safety study of proposed bevacizumab biosimilar (MYL-1402O) compared with avastin, in the first-line treatment of patients with stage IV non-squamous non-small cell lung cancer (nsNSCLC) (ESMO 2020) - P3 | "Patients received combination therapy of study treatment with carboplatin-paclitaxel (CP) up to 18 weeks (6 cycles) followed by 24 weeks (8 cycles) of monotherapy. Ltd Bangalore, India. Clinical trial identification: EudraCT Number: 2015-005141-32."

Clinical • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Population pharmacokinetics (Pop PK) of MYL‑1402O (a proposed biosimilar to bevacizumab) and reference product (Avastin) in patients with nonsquamous non-small cell lung cancer (nsNSCLC). (ASCO 2021) - P3 | "Patients received either MYL or reference product, in combination with carboplatin-paclitaxel up to 18 weeks (6 cycles) followed by monotherapy for up to an additional 24 weeks (8 cycles) . The model supported linear PK at clinical doses in patients with nsNSCLC; there were no clinically relevant/significant differences between the PK of MYL and reference product; and the findings were consistent with the PK study in normal, healthy volunteers . Bayesian Parameter"

Clinical • PK/PD data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Analytical Similarity Assessment of MYL-1402O to Reference Bevacizumab. (PubMed, Expert Opin Biol Ther) - "The totality of the data assessment confirms the high degree of similarity of MYL-1402O to reference BEV with respect to physicochemical and in vitro functional properties. The product quality data presented here, along with data from phase 1 clinical studies, demonstrate the similarity of MYL-1402O to reference BEV products, supporting further clinical development of this BEV biosimilar."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lextemy: “The CHMP noted the withdrawal of the marketing authorization [treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer]” (European Medicines Agency) - CHMP Final Minutes of the meeting on 21-24 Jun 2021

European regulatory • Breast Cancer • Colon Cancer • Fallopian Tube Cancer • Oncology • Peritoneal Cancer

Bad Miss For Biocon’s Bevacizumab In US But Firm In ’Good Place’ (Scripintelligence) - "Biocon is still awaiting a site inspection as pandemic-related delays keep its Viatris-partnered bevacizumab out of the US market, though the Indian company believes it can still make good and garner market share."

Commercial • Oncology

Abevmy: “The Committee adopted a positive opinion recommending the granting of a marketing authorization by consensus together with the CHMP assessment report and translation timetable [treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, NSCLC and renal cancer]” (European Medicines Agency) - CHMP Final Minutes of the meeting on 22-25 February 2021: "The CHMP adopted the similarity assessment report"

European regulatory • Breast Cancer • Colon Cancer • Fallopian Tube Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Rectal Cancer • Renal Cell Carcinoma