The global biosimilars market continues to expand rapidly, driven by biologics patent expirations and growing demand for cost-effective therapies. Success in this market depends on speed, precision, manufacturing consistency, and the ability to demonstrate biosimilarity through robust analytical and process development strategies.
Mabion supports partners through two flexible collaboration models:
Companies seeking a reliable manufacturing and development partner can leverage Mabion’s integrated biologics capabilities spanning cell line development, process development, GMP drug substance manufacturing, and quality support.
Beyond traditional service models, we also actively pursue co-development partnerships for organizations looking for a more strategic partnership. Within that model Mabion contributes scientific expertise, development know-how, infrastructure, and operational execution to jointly advance biosimilar assets.
By combining scientific expertise, infrastructure, and operational flexibility, Mabion helps partners transform biosimilar drugs opportunities into scalable and competitive biologics programs.
Streamlined Biosimilar Drug Development
A streamlined biosimilar development path is available as part of our services. We’ll help your drug reach market faster than the competition.
Due to the underlying objectives, development and manufacturing biosimilars is significantly different than innovators. Creating and producing a protein that is defined as “highly similar” to an existing therapeutic is in a certain way more challenging than developing and production an innovative biologics, as it requires developing processes capable of manufacturing a product which will meet the pre-set specifications of the originator on all relevant key quality attributes. Therefore, many aspects of the development and manufacturing processes for a biosimilar are guided by the reference innovator product. Confirming similarity in biosimilar drugs is a complex analytical task, which requires an advanced arsenal of equipment and robust analytical methods, all of which Mabion offers.
A successful biosimilar comparability program depends on demonstrating consistency, similarity, and control across critical quality attributes. It starts with deep physicochemical and biological characterization, continues through process and product understanding, and may be supported by targeted non-clinical or clinical studies where scientifically justified. Regulators increasingly recognize that modern analytical tools can be highly sensitive in detecting relevant product differences. Mabion supports partners in designing and executing comparability strategies by offering an integrated approach to biosimilar characterization. This ensures a clear, science-based pathway toward clinical and commercial readiness.
If you are interested in collaborating with us, contact us.
Mabion perfectly understands the challenges faced by biosimilar companies, as not long ago, we were one of them ourselves! Prior to the pandemic and transformation into a dedicated biologics CDMO, our company had a total of six biosimilars in the pipeline, at various stages of development.
We produced and supplied IMPs for Phase III clinical trials, performed across several European countries with participation of several hundred of patients.
Our main biosimilar drug candidate, MabionCD20, is being developed as an orphan drug for rare disease indications.
We went through all pre-clinical and clinical phases with our own products, building a strong expert team and gaining relevant experience which we now share with our clients.
Starting as a biosimilar developer, our company earned first-hand experience in planning, developing and running a large-scale manufacturing process for biosimilar products. We pride ourselves to be experts in manipulating cell culture conditions to obtain proteins with the exact desired characteristics – a skill of paramount importance, particularly at early-stage development of complex molecules.
Our fit-for-purpose facility possesses all equipment necessary for end-to-end manufacturing of biosimilars, operated by well-qualified and experienced specialists.
We possess extensive analytics internal, which enables us to perform full in-process quality testing and reference drug characterization.
Together, all these elements form a comprehensive manufacturing platform that can be utilized by a range of biosimilar companies, regardless of their size, product characteristics or development stage.
Fine-tuning the biosimilar production process is a complex and demanding task that is best handled by a CDMO with deep expertise in this specialized field. Even extensive experience in production innovative biologics often falls short when it comes to navigating the unique challenges of biosimilars development and production, resulting in higher risks of a delayed market release and project cost overruns.
Biosimilars are the heart and soul of our company. Before transforming into a fully focused CDMO, we spent many years designing and optimizing the manufacturing processes for several of our own biosimilar candidates.
