Market

Market opportunity

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.

$40-250 Bn

in cost savings potential for healthcare budgets in the next 10 years

up to 70%

decrease in originator biologic price

<1%

biologics treatment rate in Low & Middle Income Countries

93%

of monoclonal antibodies manufactured in US/EU

Market

Barriers

Barriers to entering the biosimilar market

Current bioproduction models prevent a global supply of affordable biosimilars:

Development

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.

Production

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.

Portfolio

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
Adalimumab
Informations

Solution

Fostering local supply of essential biosimilars

By delivering turnkey solutions, Univercells removes the barriers preventing a local supply of essential medicines.

Benefits

Affordable quality

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

Biosimilar antibody

GMP-grade cell line expressing biosimilar mAb, characterization package.

Manufacturing platform

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.

Documentation

Submission-ready CTD-formatted core registration dossier, process, testing and equipment documentation.

Case study

  • 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

      Processing area

Interested in our
biosimilar portfolio?

Contact us