Biocon Ltd. is a holding company involved in the manufacturing, research, and development of therapeutic drugs. It operates across four main segments: Small Molecules, Biologics, Branded Formulations, and Research Services. The Small Molecules segment encompasses the production of various drugs, including statins, immunosuppressants, antifungals, anti-obesity, anti-diabetics, ophthalmologicals, oncologicals, and urologicals. The Biologics segment focuses on providing products such as Insulins and Analogs, biosimilar Monoclonal Antibodies (MAbs), and recombinant proteins. The Branded Formulation segment includes therapeutic areas like diabetology, oncology, immunology, and critical care. The Research Services segment is dedicated to Syngene development platforms. Founded by Kiran Mazumdar-Shaw on November 29, 1978, Biocon Ltd. is headquartered in Bangalore, India.

Tags

Other Diseases

Endocrinology and Metabolic Disease

Nervous System Diseases

Biosimilar

Monoclonal antibody

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	9
Nervous System Diseases	8
Immune System Diseases	7
Neoplasms	5
Hemic and Lymphatic Diseases	4
Infectious Diseases	4

Top 5 Drug Type	Count

Biosimilar	13
Monoclonal antibody	7
Small molecule drug	4
Hormone	3
Fusion protein	3

Top 5 Target	Count

CGRP x CGRP receptor	2
INSR(Insulin receptor)	2
CSF-3R(Colony stimulating factor 3 receptor)	2
GLP-1R(Glucagon-like peptide 1 receptor)	2
CD20(B-lymphocyte antigen CD20)	1

Drugs associated with Biocon Ltd.

Tirzepatide

Target

GIPR x GLP-1R

Mechanism

GIPR agonists [+1]

Active Org.

Eli Lilly Canada, Inc. [+8]

Originator Org.

Lexaria Bioscience Corp. [+1]

Active Indication

Obesity [+12]

Inactive Indication

Hypoglycemia [+2]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date13 May 2022

Ibrexafungerp Citrate

Target

1,3-beta-glucan synthase

Mechanism

1,3-beta-glucan synthase inhibitors [+1]

Active Org.

SCYNEXIS, Inc. [+3]

Originator Org.

SCYNEXIS, Inc.

Active Indication

Candidiasis, Vulvovaginal [+10]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Jun 2021

Itolizumab

Target

CD6

Mechanism

CD6 inhibitors [+1]

Active Org.

Biocon Ltd. [+2]

Originator Org.

Biocon Ltd.

Active Indication

Cytokine Release Syndrome [+9]

Inactive Indication

Asthma [+4]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Jan 2013

Clinical Trials associated with Biocon Ltd.

NCT06038539 / Not yet recruitingPhase 3

A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in neoadjuvant treatment of patients with HR-ve and HER-2 positive early stage or locally advanced breast cancer.

Start Date15 Sep 2024

Sponsor / Collaborator

Biocon Ltd.

CTRI/2024/02/063260 / Not yet recruitingPhase 3

A Multicenter, Double-Blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® along with Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neo adjuvant Treatment in Patients with Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2) positive Early Stage or Locally Advanced Breast Cancer - NIL

Start Date29 Mar 2024

Sponsor / Collaborator

Biocon Ltd.

CTRI/2024/01/061637 / RecruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial toEvaluate the Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis - COSMIC – IPF

Start Date07 Mar 2024

Sponsor / Collaborator

Syngene International Ltd.

100 Clinical Results associated with Biocon Ltd.

0 Patents (Medical) associated with Biocon Ltd.

564

Literatures (Medical) associated with Biocon Ltd.

19 Jul 2024·Organic Process Research & Development

Analytical Strategy for Low-Level Estimation of Unstable Genotoxic Boronate Ester Impurities

Author: Mangalampalli, Venkata Phanikrishna Sharma ; Purandharan, Devikumar ; Gandhi, Santosh ; Jayaraman, Karthik ; Kushwah, Bhoopendra Singh ; Young, Joel ; Bajpai, Lakshmikant ; Rajendran, Ashok Kumar

Boronate esters are commonly used starting materials in the Suzuki-Miyaura coupling reaction for the C-C bond formation due to their cost-effectiveness and ease of manufacturing process.However, most of them are highly sensitive to moisture and pose challenges during their in-process anal., with conversion to acids under reversed-phase anal. conditions.They are prone to hydrolysis under moisture, pH, and even on-column stationary phases under neutral conditions.At the same time, boronate esters are considered as potential genotoxic substances; hence, their estimation is very important from the patient safety perspective.There are inherent challenges in the existing methods of anal. of these compoundsIn this paper, a convenient, simple, highly sensitive, and greener SFC-MS method was developed for the screening of such unstable boronate esters.The optimized method consisted of Celeris Arginine column (250 mm x 4.6 mm; 5μm) with CO2 (A) as a solvent with a cosolvent of ACN: MeOH (80:20) containing 0.2% 7N methanolic ammonia (B) in gradient mode [Tmin/B %: 0.01/05, 0.50/05, 5.00/50, 7.00/50, 7.10/05, and 10.00/05].Critical method parameters such as ABPR pressure, makeup solvent, additives, and pump flow rate were optimized to enhance the sensitivity with a model compound, i.e., 1-(benzenesulfonyl)-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)pyrrolo[2,3-b]pyridine (CAS number 886547-94-0).The robustness of the method was demonstrated by validating the method as per the ICH guidelines on the same model compound in the concentration range of 0.03-0.3 ppm.The LOD and LOQ for this compound were determined as 0.01 and 0.03 ppm (1 and 3 ppm with respect to API concentrations of 10 mg/mL), resp.The method was successfully applied for the estimation of 16 structurally different boronate esters with no chem. derivatization or hydrolysis.

28 Jun 2024·Organic Letters

Organic Photoredox-Catalyzed S-Trifluoromethylation of Aromatic and Heteroaromatic Thiols

Article

Author: Tester, Richland ; Mathur, Arvind ; Sarmah, Manash Pratim ; Bhattacharyya, Aditya ; Muthukumar, M ; Vadde, Veeresh

A visible-light-mediated trifluoromethylation protocol was developed for the conversion of (hetero)aromatic thiols to their respective S-trifluoromethylated derivatives employing trifluoromethanesulfonyl chloride (CF₃SO₂Cl) as a cost-effective source of trifluoromethyl radical (CF₃·) and a highly reducing organophotocatalyst, 3DPA2FBN. The developed methodology is operationally simple, providing access to a diverse range of products in up to 92% yield. A plausible mechanism has been postulated based on preliminary mechanistic studies, including irradiation on/off, UV-vis studies, and radical trapping experiments.

18 Jun 2024·ChemistrySelect

Tunable Synthesis of Pyrazolo Oxepines, Pyrazolo Thiophenes and 1H‐Indazoles Using Alkylation, Aldol Condensation and Thermal Rearrangement

Author: Gupta, Anuradha ; Akunuri, Arun ; Pavan, Mysore S. ; Byri, Vijay Kumar ; Ulaganathan, Sankar ; Pitchai, Manivel ; Chikkananjaiah, Nanjundaswamy Kanikahalli ; Vetrichelvan, Muthalagu ; Reddy, Thirupala ; Mathur, Arvind ; Venkateshappa, Suresh Shagathur

AbstractBase‐mediated alkylation of 1‐alkyl/aryl‐5‐hydroxy/mercapto‐1H‐pyrazole‐4‐carbaldehydes with functionalized 3‐bromo‐prop‐1‐enes and 3‐bromo‐1‐(arylsulfonyl)propenes followed by intra‐molecular cyclization afforded regioselective pyrazolo oxepines, pyrazolo thiophenes, and 1H indazoles respectively, with good to excellent yields. This protocol paves the way for the development of syntheses of interesting biologically active scaffolds.

211

News (Medical) associated with Biocon Ltd.

23 Oct 2024

·www.biospace.com

Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings-Catalent Merger

iStock, Robert Way Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo. Roche on Wednesday released its third-quarter earnings report , posting nearly $17.5 billion in sales, representing 9% year-on-year growth and exceeding Wall Street expectations. According to Jefferies analyst Peter Welford, Roche’s Q3 sales were 1% ahead of the consensus estimate. The company’s pharmaceuticals division, which remains its strongest unit with $13.4 billion in the quarter, beat analysts’ expectations by 2%. Roche’s top-performing asset in the quarter was the multiple sclerosis drug Ocrevus, which grew 11% to bring in almost $2 billion. Despite mounting biosimilar competition in the eye diseases space, Roche’s intravitreal injection Vabysmo continues its strong market momentum. The age-related macular degeneration (AMD) treatment surged 59% year-over-year, bringing in nearly $1.2 billion in Q3. Vabysmo, a dual inhibitor of VEGF and angiopoietin-2, is also indicated for diabetic macular edema (DME). In May 2024, the FDA greenlit two biosimilars to Regeneron’s blockbuster therapy Eylea—Samsung Bioepis and Biogen’s Opuviz and Biocon Biologics’ Yesafili—which are expected to compete with Vabysmo in the AMD and DME markets. On the negative side of the Q3 ledger, Roche’s PD-L1 antibody Tecentriq was “weak” in the quarter, according to Jefferies’ Welford, noting that its sales of just over $1 billion fell short of consensus estimates. Looking forward to the rest of the year, Roche reiterated its business outlook with growth of around mid-single-digit in group sales and in the high-single-digit range for core earnings-per-share. Opposition to Novo-Catalent Deal On the M&A front, Roche is urging regulatory authorities to block Novo Holdings’ proposed $16.5 billion acquisition of CDMO giant Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Roche CEO Thomas Schinecker said in a media call Wednesday morning, however insisting that the company itself would not be affected by the merger, according to Reuters . The acquisition would further restrict the contract manufacturing ecosystem, Schinecker said, which “could be a problem for other smaller players.” “From an industry perspective, it would be a wrong decision by authorities” if they let the transaction proceed, according to Schinecker. Pressure on the deal has been mounting. Last week, more than 10 unions, consumer organizations and public interest groups wrote to the Federal Trade Commission , urging the antitrust watchdog to “challenge” the proposed acquisition and to ensure that “competition is protected.” Sen. Elizabeth Warren (D-Mass.) earlier this month also flagged potential anti-competitive concerns with the transaction. In a letter to the FTC, Warren warned that the acquisition of contract manufacturer Catalent could increase Novo Nordisk’s dominance over the hot GLP-1 market, reducing competition and increasing prices. Referring to rival Eli Lilly, Warren said the deal could give Novo Nordisk “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices,” as well as “the ability to preference its own products and obstruct its competitors’ use of Catalent to produce GLP-1 drugs.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We do rely on one of the Catalent sites for GLP-1 and other diabetes production,” Ricks told analysts. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens.”

Acquisition

22 Oct 2024

·endpts.com

Amgen preps to launch Eylea biosimilar years early after Regeneron loses appeal

Amgen is moving forward with the launch of Pavblu, its biosimilar to Regeneron’s blockbuster Eylea, following an appeals court decision that ruled against competitor Regeneron. “We look forward to bringing Pavblu to patients as quickly as possible to help expand access to affordable and effective treatment,” Amgen said in a statement to Endpoints News . A Regeneron spokesperson said in a statement that the company is “disappointed in today’s court decision. Regeneron has invested many years of effort into its design and development of” Eylea. The spokesperson also said Regeneron continues to believe that Amgen is infringing its patent rights, and Tuesday’s decision “denying our request for a temporary injunction is not the final word in this litigation.” The drugmaker plans to appeal the decision and present its case at trial. Last month, a West Virginia district court denied Regeneron’s motion for a preliminary injunction, but an appeals court issued an order temporarily enjoining the launch of Pavblu, which was approved by the FDA in August. The appeals court has now lifted that temporary injunction. The FDA earlier this year approved the first two Eylea biosimilars — Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz. Because of remaining patents for Eylea, analysts have said they don’t expect other biosimilars to launch until 2027. Regeneron also sued Sandoz in August in New Jersey federal court over its Eylea copy, called Enzeevu.

Drug ApprovalPatent Infringement

14 Oct 2024

·www.pharmaceutical-technology.com

ENHERTU gains conditional approval in China to treat NSCLC

ENHERTU is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. Credit: Nemes Laszlo/Shutterstock. Daiichi Sankyo and AstraZeneca ‘s ENHERTU has been conditionally approved by China’s National Medical Products Administration (NMPA) as a single agent for adult patients with a specific type of non-small cell lung cancer (NSCLC). Free Whitepaper Intensified Biomanufacturing of monoclonal antibodies Using an intensified fed-batch process is a viable alternative for higher protein production at a large scale without expanding the current manufacturing footprint. Syngene’s expertise in the field is covered in this white paper. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. Go deeper with GlobalData Reports LOA and PTSR Model - DF-9001 in Non-Small Cell Lung Cancer Reports LOA and PTSR Model - Eniluracil in Metastatic Breast Cancer Data Insights The gold standard of business intelligence. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The therapy is indicated for patients with unresectable or metastatic NSCLC with activating HER2 mutations who have previously undergone systemic therapy. It marks the fourth approval in China for ENHERTU, which has been authorised for use in three different tumour types: HER2-low metastatic breast cancer, and HER2-positive advanced or metastatic gastric cancer . ENHERTU, a HER2-directed antibody-drug conjugate (ADC), was discovered by Daiichi Sankyo and is being developed and commercialised in collaboration with AstraZeneca. The conditional approval is based on the outcomes of the DESTINY-Lung02 and DESTINY-Lung05 Phase II studies. See Also: Evergreen Theragnostics Radiopharmaceutical Manufacturing Facility, New Jersey, US Merck Biotech Development Center, Corsier-sur-Vevey, Switzerland In the DESTINY-Lung02 trial, ENHERTU achieved the primary endpoint with a confirmed overall response rate (ORR) of 49%, 49 partial responses (PRs) and one complete response (CR), as evaluated by blinded independent central review (BICR). The DESTINY-Lung05 trial demonstrated a confirmed ORR of 58.3%, one CR and 41 PRs, as determined by an ICR. AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “This approval of ENHERTU represents the first HER2 directed therapy approved in China for the treatment of HER2 mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. “It also reinforces the importance of testing for predictive biomarkers, including HER2 mutations in lung cancer at the time of diagnosis, to ensure patients can receive the most appropriate treatment for their specific disease.” The full approval of ENHERTU for this indication in China will depend on the clinical benefits observed in the confirmatory trial. Enhertu was approved in the US as the first tumour-agnostic HER2-directed therapy in April 2024 for previously treated patients with metastatic HER2-positive solid tumours. Free Whitepaper Intensified Biomanufacturing of monoclonal antibodies Using an intensified fed-batch process is a viable alternative for higher protein production at a large scale without expanding the current manufacturing footprint. Syngene’s expertise in the field is covered in this white paper. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. 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Clinical ResultDrug ApprovalPhase 2ADC

100 Deals associated with Biocon Ltd.

100 Translational Medicine associated with Biocon Ltd.

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Pipeline

Pipeline Snapshot as of 18 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Epoetin alfa biosimilar(Biocon Biopharmaceuticals Pvt Ltd.) ( EPO receptor )	Anemia More	Approved
Recombinant human insulin(Biocon Ltd.) ( INSR )	Diabetes Mellitus More	Approved
AFLIBERCEPT-JBVF ( PGF x VEGF-A )	Diabetic Retinopathy More	Approved
Nimotuzumab ( EGFR )	Head and Neck Neoplasms More	Approved
Liraglutide biosimilar(Biocon Limited) ( GLP-1R )	Diabetes Mellitus, Type 2 More	Approved

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