Biosimilars
Overview
Biosimilars
As the number of biologics going off-patent increases biosimilar medicines become increasingly appealing to healthcare organizations, physicians, and patients by offering greater choice and a more cost-effective option.
The development of biosimilar medicines involves rigorous analytical studies to thoroughly understand their similarity to the reference product. Toxicity assessments and clinical studies are also conducted to further confirm this similarity. The ultimate goal is to demonstrate that, based on these findings, there are no clinically meaningful differences between the reference product and the biosimilar.
| # | GNG Code | Molecule | Disease Indication | CLD | RCB | PD | Pre-clinical |
|---|---|---|---|---|---|---|---|
| 01 | BSP001 | Golimumab Anti-TNF monoclonal antibody Autoimmune / Inflammatory |
Rheumatoid arthritis, Psoriasis & Ulcerative Colitis | ||||
| 02 | BSP002 | Dostarlimab Anti-PD-1 checkpoint antibody Oncology |
Colorectal & Rectal Cancer | — | |||
| 03 | BSP003 | Pembrolizumab Anti-PD-1 checkpoint inhibitor Oncology |
Non-small cell lung carcinoma, Head and neck cancer | — | |||
| 04 | BSP004 | Nivolumab Anti-PD-1 checkpoint inhibitor Immunotherapy |
Non-small cell lung carcinoma, Head and neck cancer | — | — | ||
| 05 | BSP005 | Daratumumab Anti-CD38 monoclonal antibody Hematology / Oncology |
Multiple Myeloma | — | — | ||
| 06 | BSP006 | Trastuzumab Anti-HER2 monoclonal antibody Oncology |
HER2-positive breast cancer, HER2-positive gastric cancer | — | — | — | |
| 07 | BSP007 | Dupilumab Anti-IL-4Rα monoclonal antibody Immunology |
Atopic dermatitis, Asthma | — | — | — | |
| 08 | BSP008 | Denosumab Anti-RANK-L monoclonal antibody Oncology / Bone |
Osteoporosis, Bone loss due to cancer therapy | — | — |
Biosimilar Development Services - End-to-End. Regulatory-Ready. Built in India
As more biologics lose patent protection, the pressure to bring a high-quality, cost-competitive biosimilar to market faster and with full regulatory confidence has never been greater. Choosing the right biosimilar CRO partner from the start makes all the difference.
At GeNext Genomics (GNG), we are India’s trusted end-to-end biosimilar development CRO, offering comprehensive biosimilar development services from reference product analysis and biosimilar antibody development through preclinical material generation for biosimilar programs and rigorous analytical characterization for biosimilar comparability studies; All under one ISO 9001:2015 certified roof, with flexible partnership structures designed around your program’s needs.
Biosimilar Development Services
At GNG, we provide comprehensive biosimilar development services, guiding you through the intricate process of bringing a high-quality biosimilar to market. Our expertise ensures your biosimilar meets all regulatory requirements and matches the safety and efficacy of the reference product.
Reference Product Analysis
We start by selecting and thoroughly analyzing the reference biologic product. Our advanced analytical techniques ensure a detailed structural and functional comparison.
Cell Line Development
We assist you in choosing the optimal expression system, conducting engineering, and selecting the best cell clones to maximize biosimilar production and quality.
Process Development
Our team optimizes both upstream and downstream processes. This includes refining cell culture conditions and developing efficient purification methods to ensure high yield and purity.
Analytical Characterization
We conduct extensive physicochemical and biological characterizations to ensure your biosimilar closely matches the reference product in structure and function. Immunogenicity assessments are also performed to predict and evaluate potential immune responses.
Pre-Clinical Studies
We provide support of in vitro and in vivo studies to compare the activity, pharmacokinetics, pharmacodynamics, and toxicity of the biosimilar with the reference product.
Unlock Value with Flexible
Partnership Structures
We specialize in developing biosimilar cell lines and process know-how. By independently creating and owning all assets, we provide a range of partnership structures tailored to your needs. Contact us to accelerate your biosimilar development process efficiently.
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