Biosimilars increasing accessibility of biologics
Biosimilars promote the affordability of highly effective medicines for often debilitating or life-threatening diseases, improving access to treatment and relieving public health budgets.
Particularly in less privileged countries, where patients are often deprived of essential treatment for economical reasons, biosimilars have a major impact.
in cost savings potential for healthcare budgets in the next 10 years
up to 70%
decrease in originator biologic price
biologics treatment rate in Low & Middle Income Countries
of monoclonal antibodies manufactured in US/EU
Barriers to entering the biosimilar market
Current bioproduction models prevent a global supply of affordable biosimilars:
Biosimilar development requires deep knowledge of bioprocess engineering, analytical sciences, manufacturing technology, clinical pharmacology and regulatory affairs, to name a few. Besides knowledge, it takes substantial investment and several years of work from project start to product launch. These obstacles form an important deterrent for companies to enter the biosimilars space.
In the contemporary manufacturing model, medicines are manufactured for global supply in one or a limited number of facilities clustered in a few regions world-wide. Such centralized manufacturing units achieve low COGS through large product volumes, creating two formidable barriers for new entrants: the investment required for large-scale production facilities and equipment, and the dependence upon sufficient sales volumes to ensure economical viability.
Increasing accessibility of biosimilars
Univercells is developing a portfolio of biosimilar monoclonal antibodies targeting auto-immune diseases to be delivered at an affordable cost. Univercells bioproduction platform addresses the need of small volume, cost-efficient production of biosimilars to meet regional demands.
|Preclinical development||Clinical PK/PD||Clinical efficacy / safety||Registration|
Fostering local supply of essential biosimilars
By delivering turnkey solutions, Univercells removes the barriers preventing a local supply of essential medicines.
A high-performance microfacility and process at a low cost, for inexpensive manufacture of a biosimilar product meeting EU quality standards
Accelerated market access
Readily available product development data in a registration-ready format, offering a short and de-risked path to regulatory submission and market approval
Favorable societal impact
Increasing access to affordable biologics and promoting the development of the local biotechnology sector
CLICK & LEARN
GMP-grade cell line expressing biosimilar mAb, characterization package.
Compact manufacturing platform for cost-effective and high-quality production of drug substance.
Modular facility design
Rapid deployment in new or existing asset, delivering flexible facilities at low CAPEX.
Technology transfer & training
Transfer of manufacturing process and technology, thorough training for transfer of know-how.
Submission-ready CTD-formatted core registration dossier, process, testing and equipment documentation.
Adalimumab biosimilar production
Breaking away from the economies of scale paradigm, this solution is ideal to target small to medium-size markets.
With a high-performance production platform delivering optimized operational costs, manufacturers can rapidly implement a sustainable biosimilar production for regional supply.
Target capacity: 30 kg/year
Solution accommodates 5-50 kg / year
Target CoGs: <200 €/g
For drug product
Target processing footprint < 100 m²