BioXpress Therapeutics
Pioneering Biosimilars with Expertise and Innovation

The overarching objective behind developing biosimilars is to offer cost-effective alternatives to established biological drugs. Accomplishing this is not simple, as it demands manufacturers to incorporate innovative manufacturing approaches to reduce costs in their existing processes.

This is where BioXpress Therapeutics comes into play.

By pushing the boundaries of innovation in biosimilar manufacturing, the company ensures that patients—the ultimate beneficiaries—can access high-quality, effective treatments at a fraction of the cost of the original medications. One of its core focus areas is developing monoclonal antibody (mAb) biosimilars— for critical applications like cancer, inflammation, and autoimmunity—using advanced manufacturing techniques.

The company’s mission is to curate a production methodology that optimises efficiency and minimises costs, allowing clients to offer biosimilars at a considerably lower price than innovator drugs.

“While our competitors explore different biopharmaceutical areas to expand their offerings, we remain committed to driving biosimilars forward. This focus sets us apart in the market,” says Gerrit Hagens, director of BioXpress Therapeutics.

BioXpress’s success lies in the collaboration it fosters within its team of specialised professionals. Each member boasts 20 to 25 years of experience in the biotech industry. This vast knowledge base enables it to cover every aspect of biosimilar development, including cell line creation, manufacturing process improvement, and analytical techniques.

Exemplifying the team’s success are the 12 originator biologics they actively contributed to developing. These include mAbs like Herceptin^®, Rituxan^®, Avastin^®, Xolair^®, Vectibix^®, Xgeva^®, and Humira^®.

In the current pharma landscape, biosimilars must demonstrate comparable clinical efficacy to their innovative counterparts. This evaluation often takes place during phase I clinical trials. Usually, the tests assess pharmacokinetics (PK), pharmacodynamics (PD), and potential immunogenicity rather than efficacy.

Furthermore, they are smaller in scale than phase I studies conducted for innovator products. These aspects underscore the importance of maintaining a consistent comparison with the innovator in clinical and non-clinical stages throughout the development process.

Aligned with this principle, BioXpress ensures synchronisation across every stage of biosimilar development with innovator standards. This involves employing their product for characterisation and ongoing performance benchmarking. It also emphasises maintaining high biosimilarity via stringent controls and adept implementation of leading-edge evaluation equipment. Building on these competencies, BioXpress’s team reduces clinical trial-related risks, which is critical as a robust trial process is the foundation for efficient, ethical, and cost-effective biosimilar development. They also consider the inherent variability of a potential biosimilar to minimise uncertainty and imbue confidence in its movement across trial phases while maintaining comprehensive control throughout production.

Central to BioXpress’s competencies are cutting-edge manufacturing processes proven to enhance cost-effectiveness. Unlike many competitors that rely on age-old methods, it flexibly integrates new advancements to cultivate highly productive cell lines.

These enable the company to produce high-quality biosimilars in large quantities and set them apart from contract development and manufacturing organisations that often face limitations due to deeply rooted production methodologies.

It also embraces the latest technological advancements, including innovative, continuous, and intensified manufacturing processes, to fulfil the commitment of providing cost savings and consistent product quality.

Interestingly, BioXpress refrains from commercialising products under its brand. Instead, its strategy revolves around licensing developments to companies with established networks and expertise in sales and marketing. This strategic decision acknowledges the complexity of successful market entry, enabling clients to reliably develop affordable biosimilars and bring them to market within desired timelines.

Positioned as a global biosimilar industry leader, BioXpress firmly believes that everyone should have access to high-quality biologic therapeutics. Placing this tenet at its core, the company continues to bring faster, safer, and more efficient biosimilar development, enhancing the quality of life for patients worldwide.