WHO WE ARE
Our Vision
Our vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them with an access to high quality and cost-effective biosimilars.
Our Mission
Deliver exceptional value to stakeholders and better health outcomes to patients by becoming a leading global biosimilars developer by 2030.
Build deep capabilities in development and manufacturing to deliver quality and cost-effective biosimilars for patients across the globe.
Create a sustainable and broad portfolio of biosimilars with a focus on oncology and immunology therapies.
OUR STRATEGY
Business Strategy
Our biosimilars business strategy is built around the following five core themes:
- Focus on Oncology and Immunology segments
- Invest in deep development capabilities and in-house manufacturing
- Commercialise in EU and EMs, with select products for the US markets
- Deliver sustainable growth and create long term value through a carefully selected product pipeline
- Provide clinical and economic benefit to patients through affordable and high quality biosimilars
OUR STRATEGY
Regulatory Strategy
Most regulatory authorities are working towards a standard framework for biosimilars development as more evidence about their safety and efficacy is becoming available.
The need for efficacy trials to the subject of interchangeability are being debated as new regulatory guidelines become available.
Wherever possible, CuraTeQ has strategically adopted an abridged licensure approach to push the time-to-market barriers and shorten product development timelines by:
- Demonstrating analytical biosimilarity and PK/PD comparability vis-a-vis the reference product
- Having early engagement with regulatory agencies (US FDA, EMA, MHRA etc.) to obtain the necessary buy-ins about Phase 3 clinical study requirements
- Leveraging feedback from regulatory agencies to address any “residual uncertainty” based on the evidence of analytical biosimilarity and clinical pharmacology assessment
We believe to the extent possible, efficacy trials in patients may not be always necessary provided biosimilarity can be proven through a thorough analytical assessment and PK/PD studies.
Having said that, CuraTeQ Biologics believes in constructively engaging with the regulatory agencies and doing what is necessary to bring these life saving biosimilars to the patients across the globe.
As on date, CuraTeQ Biologics has filed three biosimilars with regulatory agencies based on analytical biosimilarity and PK/PD data, while we are also conducting Phase 3 clinical studies for three of our other products.
What are Biosimilars?
References:
- US FDA: Section 351(k) of the PHS ACT (42 U.S.C. 262(k)), 2010.
- MHRA: Guidance on the Licensing of Biosimilar Products, 2022.
- EMA: Guideline on Similar Biological Medicinal Products, CHMP/437/04 Rev 1, 2015.
- DBT-CDSCO: Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India, 2016.
Evolving Paradigm for Biosimilars1
Reference Product
Current Biosimilar Product
Future Biosimilar Product
References:
1. Adapted from “BsUFA III Regulatory Research Pilot Program: Research Roadmap, 2023
OUR CAPABILITIES
Development Capabilities
The CuraTeQ Biologics R&D Centre has a footprint of 33,000 sq. ft and employs more than 125 scientists.
A number of PhDs are involved in developing our portfolio of biosimilars.
Key features of our R&D capabilities:
Cell line development
Fermentation sciences
Mammalian cell culture
Protein purification
Process characterisation
Analytical product characterisation
Formulations
Cell based functional assays
Clinical immunology
Scale down and scale up
OUR CAPABILITIES
cGMP Capabilities
Our biosimilars manufacturing centre in Hyderabad, India, is an EU GMP certified fully integrated commercial scale facility.
It has end-to-end capabilities in producing a full range of products from bulk drug substance (DS) to fill-finish and packaged drug products (DP).
Key features of our EU GMP certified facilities:
140,000 sq. ft. ‘EU GMP certified’ manufacturing facility
Mammalian Drug Substance manufacturing section housing four 2500 L scale SS bioreactors
Microbial Drug Substance manufacturing section housing two 250 L scale SS bioreactors
Segregated filling sections for Vials and Pre-filled syringes/cartridges
Systems designed as per 21 CFR Part 11, and GAMP 5 ISPE guidelines
QC testing laboratories for products lot release, raw material, packaging material, microbiology and sterility testing
Centrally located warehouse for ease of servicing various manufacturing sections
Designed for optimal man and material movement to mitigate cross contamination
Designed for automated Clean-In-Place (CIP) and Sterilisation-In-Place (SIP) operations
Automated buffer distribution and handling capabilities
Continuous monitoring through Building Management Systems (BMS)
Water for Injection (WFI) generation facility with cold and hot loops
Latest News
12 November 24
EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad
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15 March 24
CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar
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17 February 24
Auro Peptides completes US FDA inspection with zero observations
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17 January 24
CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India
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20 November 23
CuraTeQ Biologics eyes ‘WuXi’ moment to kickstart Indian bio-CDMO sector
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10 July 23
CuraTeQ Biologics to market Ustekinumab biosimilar to treat Crohn’s disease, arthritis
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05 July 23
CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar
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12 January 22
Aurobindo Pharma arm CuraTeQ expands scope of biosimilars distribution pact with Orion
Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope…
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12 February 17
Aurobindo Pharma forays into biosimilars development
Aurobindo Pharma Limited is pleased to announce the acquisition of four cell culture derived biosimilar…
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