Biocon Biologics UK PLC
Biocon Biologics Limited is a global biosimilars company with capabilities across discovery, CMC, large-scale biologics manufacturing, clinical development, analytical characterization, regulatory submissions and pharmacovigilance. The company operates multi-site manufacturing, conducts randomized clinical and PK/PD studies (including euglycaemic clamp studies for insulins), publishes peer-reviewed research, and has obtained marketing authorizations and market entries in multiple jurisdictions including the European Union, United States, Canada and Japan.
Industries
Nr. of Employees
Very Large (1000+)
Biocon Biologics UK PLC
Bangalore, Karnataka, India, Asia
Patents
Integrated automated filtration for separation, washing and drying of peptide crystals
US-11472835-B2
View DetailsMethods for reducing accumulation of lactate during culturing and method for producing polypeptide
US-9670519-B2
View DetailsMethod for reducing heterogeneity of antibodies and a process of producing the antibodies thereof
US-9631216-B2
View Details
Integrated automated filtration for separation, washing and drying of peptide crystals
US-11472835-B2
View DetailsMethods for reducing accumulation of lactate during culturing and method for producing polypeptide
US-9670519-B2
View DetailsMethod for reducing heterogeneity of antibodies and a process of producing the antibodies thereof
US-9631216-B2
View DetailsProducts
Global biosimilars portfolio (insulins, monoclonal antibodies, recombinant proteins)
A portfolio of biosimilar therapeutics developed and commercialized for global markets, covering insulin products, monoclonal antibodies and recombinant protein therapeutics.
Global biosimilars portfolio (insulins, monoclonal antibodies, recombinant proteins)
A portfolio of biosimilar therapeutics developed and commercialized for global markets, covering insulin products, monoclonal antibodies and recombinant protein therapeutics.
Expertise Areas
- Biosimilars development
- CMC and bioprocess scale-up
- Analytical development and bioanalytical quantification
- Clinical trial management and bioequivalence/PK‑PD studies
Key Technologies
- Yeast expression systems (Pichia pastoris)
- Mammalian cell culture for monoclonal antibodies
- Upstream and downstream bioprocess development
- Analytical assay development and stability testing
News & Updates
Press release announcing marketing authorisation by the European Commission for denosumab biosimilars indicated for bone-related indications.
Announcement of U.S. market availability for an adalimumab biosimilar and related product presentation (prefilled pen) and commercial access options.
Randomized, double-blind, crossover euglycaemic clamp study reporting PK/PD bioequivalence of an insulin aspart biosimilar using immunoaffinity purification and LC‑MS/MS quantification.
Phase III randomized trial demonstrating comparable efficacy and safety between a trastuzumab biosimilar and reference trastuzumab in HER2-positive metastatic breast cancer.
Marketing authorisation granted by the European Commission for denosumab biosimilars (multiple product presentations) following CHMP positive opinion.
Commercial launch and availability of an adalimumab biosimilar in the United States, including prefilled pen presentation.
Press release announcing marketing authorisation by the European Commission for denosumab biosimilars indicated for bone-related indications.
Announcement of U.S. market availability for an adalimumab biosimilar and related product presentation (prefilled pen) and commercial access options.
Randomized, double-blind, crossover euglycaemic clamp study reporting PK/PD bioequivalence of an insulin aspart biosimilar using immunoaffinity purification and LC‑MS/MS quantification.
Phase III randomized trial demonstrating comparable efficacy and safety between a trastuzumab biosimilar and reference trastuzumab in HER2-positive metastatic breast cancer.
Marketing authorisation granted by the European Commission for denosumab biosimilars (multiple product presentations) following CHMP positive opinion.
Commercial launch and availability of an adalimumab biosimilar in the United States, including prefilled pen presentation.