mAbxience is a world-leading fully-fledged biotech company, with over a decade of experience in the development, manufacturing and commercialisation of biopharmaceuticals. Based in Spain, mAbxience has developed an efficient business model that combines rapid development analytics with a strong track record of attracting leading global commercial business to business partnerships, which as of today includes a network of more than 100 key market leaders in Europe, the US, Japan and emerging markets.

Deeply committed to global quality and safety standards to supply its biopharmaceuticals worldwide, mAbxience’s go-to-market strategy focuses on developing and manufacturing products that are subsequently out-licensed to strong commercial partners while retaining intellectual property rights. In addition, mAbxience offers a reliable and world-class biological contract development and manufacturing (CDMO) platform through state-of-the-art cGMP multi-product facilities and cutting-edge technology transfer expertise with the capability to provide end-to-end solutions to production needs, from small research and development (R&D) and clinical batches to commercial supply. It is constantly expanding global capacities and capabilities with flexibility in scale from 20 litres to 4,000 litres of single-use bioreactors, to provide the highest service to its biopharma partners.

Its mission is to deliver solutions and bring hope to as many patients as possible, ensuring access to treatments and contributing to the sustainability of healthcare systems worldwide.

Emmanuelle Lepine, CEO of mAbxience, shares her thoughts on the company’s achievements and future goals.

What do you feel is mAbxience´s greatest achievement to date?

To have evolved over the past decade to where we are today, one of the most experienced developers and manufacturers of high-quality biopharmaceutical products is an incredible achievement. Last year we received our EMA approval for our bevacizumab brand Alymsys® and earlier this year a first cycle approval from FDA in the US. Our commercial partnership networks have ensured that the launch in Europe has been an outstanding success and we anticipate similar successful launches this year in US and Japan.

How is mAbxience approaching market access in the US?

The future of biosimilars in the US is exciting, not only because of their potential to lower the costs of biologic medicines and to make care more accessible to patients, but also because they will create space for new innovations and scientific breakthroughs.

We have, in collaboration with our local partner in the USA, recently obtained the FDA approval for Alymsys®. As a company, supporting this milestone is a great example of how innovation and cutting-edge R&D technology can be applied to create high-quality medicines that improve access to critical treatments.

What exciting challenges lies ahead?

During our evolution, we have significantly expanded both our development and manufacturing capabilities, to the point where in 2023 we will be able to offer close to 50,000 litres of manufacturing capacity in a variety of scales from small scale 20 litres right up to 4,000 litres, all of which utilises the latest state of art single-use technology. We intend to continue offering our unique blend of capacity and experience to other companies who are looking for opportunities to optimise their development, accelerate scale-up and drive efficient commercial manufacturing processes, so will be expanding our CDMO offerings through the remainder of 2022 and beyond.

How did you achieve so much success in such a short time?

It is important to reflect on how mAbxience to date is the only privately-owned company with less than 600 people to have developed, manufactured and launched a monoclonal antibody biosimilar in the Global market and that includes meeting the demanding standards of FDA, EMA and PMDA. It has been a very long and arduous road to get to this moment. It has been possible because our team have all pulled in the same direction with passion, experience, and commitment. We believe in agility and flexibility and have approached this market from the perspective of aiming to be faster and more efficient, whilst still keeping a strong focus on quality and process.

What about mAbxience vision 2025?

Our ambitious vision for the coming years is one that embraces our ability to provide affordable medicines that drive a positive impact on patients, caregivers and healthcare professionals by enhancing strategic focus and optimising the impact of biosimilars on the field.

We have a vision that by 2025 we will have launched five products, have our products treating patients across five continents and have created an efficient process allowing us to reduce the development time of a biosimilar to five years. We also plan to have reached full expansion of our manufacturing and development platform to serve more partners with high-quality products and services across the globe.