BIOPHARMACEUTICAL DEVELOPMENT

Over ten years of experience in biologic medicines

PIPELINE

A growing portfolio to increase patient access to high quality treatments

We are specialists in biologics: we have developed and commercialized two biosimilar medicines for oncology, available to thousands of patients across the globe via our B2B partnerships in worldwide markets: MB01 rituximab biosimilar and MB02 bevacizumab biosimilar, since 2014 and 2016 respectively. Now we have a highly attractive pipeline of biosimilar and innovative biopharmaceuticals targeting areas of oncology, hematology, osteoporosis and pediatrics.

Our development of biopharmaceuticals adheres to a strict “quality by design” standard using the latest innovations in upstream, downstream and cutting edge-analytics. We guarantee all biosimilars are equivalent in terms of quality, safety and efficacy to the reference products, by subjecting the drugs to exhaustive comparability testing and clinical trials, regulated by the competent authorities.

RESEARCH & DEVELOPMENT

In-house R&D competencies set apart our development of biopharmaceuticals

Our highly experienced team has specialist knowledge of chemistry and biochemistry related to biopharmaceuticals. Thanks to our in-house R&D platform, we ensure maximum control over quality and delivery of development programs.

  • End-to-end expertise and capabilities across development of the cell line, formulation, manufacturing processes for DS and DP.

  • Strong internal IP and regulatory teams ensure freedom to operate at every stage of development.

  • Outstanding regulatory capabilities with strong leadership in submissions and scientific review processes; established track records with regulatory authorities worldwide.

Biosimilar Development: Quality by Design
Use of similar CHO expression cell lines as for RMP
Identical amino acid sequence to reference medical product (RMP)
Clinical trials
Relevant non-clinical data to confirm similarity
Comprehensive physicochemical & bio-functional data from head-to-head characterization
Same pharmaceutical form as RMP & liquid formulation proprietary to mAbxience
Risk assessment & manufacturing process development following principles of the Quality by Design approach to ensure similarity
Quality target product profile based on broad experimental data set from RMP
State-of-the-art analytical methodology

PARTNERSHIPS

Our strategic alliances give us access to 100+ markets across the globe

We have established alliances with key partners, granting patients access to our quality medicines across the globe. Currently, we have a presence in over a hundred markets worldwide through network of over 30 global and regional partners, and we focus on structuring strategic partnerships for new products across the regulated markets.

At mAbxience, we work to ensure supply of affordable medicines to health care systems worldwide, adapting to the needs of each regulatory and commercial environment. We are committed to providing excellence for all our partners — we achieve this by our world-class manufacturing, a mature and efficient supply chain and the flexibility to adapt to the commercial challenges faced by each market.