Biosimilars - CuraTeQ Biologics

Biosimilar Drugs Company Manufacturing Facility

Curing people. Healing lives.

Vision and Strategy

“Improving patient access through high quality biosimilars”.

CuraTeQ’s vision is to become a highly valued biosimilars partner to the world pharma fraternity by continuously researching, developing and manufacturing a wide range of biosimilar products that comply with the highest regulatory standards.

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 process development, product characterisation, 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.

Business Strategy

Our biosimilar business strategy is built around 5 themes

Arenas

Where will the business unit be active?

Focus on Oncology, Immunology, and Respiratory biosimilars development
Targeted commercialisation in US, EU, and emerging markets through direct presence and strategic supply chain and distribution partnerships

Vehicles

How will we get there?

Wave 1 pipeline biosimilars filed or in Phase 3 trials
Advancing Wave 2 pipeline products
Integrated manufacturing footprint in India

Economics

Where is the growth and value creation?

A 10 year vision with a strategically constructed biosimilar product pipeline
Our biosimilars pipeline is expected to deliver a $50bn branded biologics opportunity
Our sustainable pipeline will deliver revenue for long term growth and value creation

Stages

What is the speed of our launches and initiatives?

Manufacturing facilities are built, operational and are compliant with global regulatory standards
Ready to commercialise first set of biosimilar products
Targeting 1 to 2 global filings every year from 2023

Differentiation

How do we intend to differentiate and win?

Operational efficiency through strategically co-located R&D and Manufacturing
Clinical efficiency through parallel product trials and prudent geographic selection
One product – One quality for all approach
Capacity footprints designed to expand with adequate real estate

Arenas

Vehicles

Economics

Stages

Differentiation

Portfolio Strategy

Our risk balanced portfolio delivers meaningful benefits to the business and patients alike.

With a strategic business mindset and patient-centric view, we are continually evolving and expanding our product portfolio across various therapeutic segments, including oncology, immunology, ophthalmic, respiratory, chronic diseases, and metabolic disorders. Our strategic vision helps sustain our efforts to develop high quality biosimilars to bridge the unmet need of democratised patient access to affordable and essential biologic medicines.

Biosimilar Drug Manufacturing and R&D Strategy

Producing high quality, complex biosimilar drugs requires robust scientific methodology and advanced manufacturing processes.

‘End-to-end capabilities’ – from clone development to commercial manufacturing
‘Validated product development platform’ (Lonza’s GS Xceed with CHO-GS cell lines) which maximizes protein expression and enables scalable processes
‘Totality of evidence’ approach involving extensive product and process characterization, coupled with comprehensive review of clinical and non-clinical data to prove biosimilarity.
‘Identical manufacturing standards’ between CuraTeQ biosimilars and reference biological products
Robust ‘scale-up’ and ‘scale-down’ approach enabling faster process development and characterization with seamless transfer from R&D to commercial manufacturing operations
‘Quality by Design’ (QbD) approach across product development lifecycle from establishing product quality attributes to commercial manufacturing

Biosimilar Regulatory and Clinical Strategy

CuraTeQ has strategically adopted an abridged licensure approach to push the time-to-market barriers and shorten product development timelines by:

Demonstrating regulatory efficiency at each step of product development, and devising a wholesome product life cycle development approach
Having early, formal, and phase appropriate engagements with regulatory agencies (US FDA, EMA, MHRA etc.) to obtain regulatory buy-ins
Leveraging feedback and scientific advice from regulatory agencies and filing our products with robust bioanalytical similarity packages and Phase 1 clinical trial data alone

Embracing the synergy of prudent scientific, commercial, and regulatory strategies, we at CuraTeQ aspire to be reliable global providers of high-quality biosimilar products.

Latest News

CuraTeQ Biologics announces positive Phase 3 study results for Denosumab biosimilar

Press Release

19 September 25

CuraTeQ Biologics announces positive Phase 3 study results for Denosumab biosimilar

CuraTeQ Biologics receives EC marketing authorization for Dazublys – Trastuzumab biosimilar

Press Release

04 July 25

CuraTeQ Biologics receives EC marketing authorization for Dazublys – Trastuzumab biosimilar

CuraTeQ Biologics receives CHMP positive opinion for Dazublys – Trastuzumab biosimilar

Press Release

26 April 25

CuraTeQ Biologics receives CHMP positive opinion for Dazublys – Trastuzumab biosimilar

CuraTeQ Biologics successfully completes Phase I study for Denosumab biosimilar

Press Release

10 April 25

CuraTeQ Biologics successfully completes Phase I study for Denosumab biosimilar

CuraTeQ Biologics receives CHMP positive opinion for Pegfilgrastim biosimilar

Press Release

31 January 25

CuraTeQ Biologics receives CHMP positive opinion for Pegfilgrastim biosimilar

CuraTeQ Biologics receives UK MHRA approval for Bevqolva™ (Bevacizumab biosimilar)

Press Release

21 December 24

CuraTeQ Biologics receives UK MHRA approval for Bevqolva™ (Bevacizumab biosimilar)

CuraTeQ Biologics receives CHMP positive opinion for Filgrastim biosimilar

Press Release

13 December 24

CuraTeQ Biologics receives CHMP positive opinion for Filgrastim biosimilar

EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad

Press Release

12 November 24

EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad

CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar

Press Release

15 March 24

CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar

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Curing people. Healing lives.

Curing people. Healing lives.

Vision and Strategy

“Improving patient access through high quality biosimilars”.

Our Mission

Business Strategy

Arenas

Vehicles

Economics

Stages

Differentiation

Arenas

Vehicles

Economics

Stages

Differentiation

Portfolio Strategy

Biosimilar Drug Manufacturing and R&D Strategy

Biosimilar Regulatory and Clinical Strategy

Latest News

CuraTeQ Biologics announces positive Phase 3 study results for Denosumab biosimilar

CuraTeQ Biologics receives EC marketing authorization for Dazublys – Trastuzumab biosimilar

CuraTeQ Biologics receives CHMP positive opinion for Dazublys – Trastuzumab biosimilar

CuraTeQ Biologics successfully completes Phase I study for Denosumab biosimilar

CuraTeQ Biologics receives CHMP positive opinion for Pegfilgrastim biosimilar

CuraTeQ Biologics receives UK MHRA approval for Bevqolva™ (Bevacizumab biosimilar)

CuraTeQ Biologics receives CHMP positive opinion for Filgrastim biosimilar

EMA grants GMP certificate to CuraTeQ Biologics’ manufacturing facility in Hyderabad

CuraTeQ Biologics successfully completes Phase 1 trial for Omalizumab biosimilar