A biosimilar manufacturer: BioXpress Therapeutics SA

April 27, 2012 1:01 PM

Located in Geneva, Switzerland, BioXpress Therapeutics SA is a provider of high-quality biologic APIs (mAb and mAb-like biosimilars) for unmet need indications, such as cancer, inflammation and autoimmunity.

Since Q2 2010, BioXpress Therapeutics has completed the validation of protein sequence, cell line development, analysis of production cell line, and pre-Phase I clinical plans for three BioXpress Therapeutics biosimilar drugs. The cell line development for BioXpress Therapeutic’s fourth drug has been initiated by the company.

The mAb-based drug market is one of the fastest growing categories of the biopharmaceuticals industry. These products are of high value for pharmaceutical industry, both in research as well as drug development activities. By 2011, biologics worth $18 billion USD in annual sales are expected to lose patent protection in developed countries and by 2018, over half of the approved mAbs will have lost patent protection, thus increasing the potential market size by a factor of at least 5 fold.

The worldwide market for biosimilar medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as a raft of branded drugs lose patent cover. Of those, monoclonal antibody therapeutics are forecasted to grow at a CAGR approaching 10% over the next five years, driven largely by positive results in the clinic. Cancers and immune-related inflammatory diseases will continue to be leading markets for monoclonal antibodies during the five-year forecast period.

BioXpress Therapeutics is focused on developing monoclonal antibodies and in addition to the 4 biosimilar monoclonal antibody drugs that are already in development, there are 14 additional mAbs in the pipeline.  The company is trying to develop the highest quality products under strict European Medicines Agency (EMA) guidelines.

The pipeline of the company shows us that, they are also interested in “less famous” biologics. Like all other manufacturers, BioXpress is developing etanercept, infliximab, trastuzumab, rituximab but to see natalizumab, omalizumab or palivizumab in pipelines is not usually possible.

Here is the full list of biosimilar pipeline of BioXpress:
Abatacept (Orencia), Adalimumab (Humira), Alemtuzumab (Campath, MabCampath), Bevacizumab (Avastin), Cetuximab (Erbitux), Denosumab (Xgeva, Prolia), Etanercept (Enbrel), Golimumab (Simponi), Infliximab (Remicade), Natalizumab (Tysabri), Ofatumumab (Arzerra), Omalizumab (Xolair), Palivizumab (Synagis), Panitumumab (Vectibix), Rituximab (Rituxan, Mabthera), Tocilizumab (Actemra, RoActemra), Trastuzumab (Herceptin) and Ustekinumab (Stelara).

To develop and launch some of these products will not be possible in the near future due to patent limitations in certain areas like EU and USA but to have 18 biosimilar candidates in the pipeline and to be able to develop them is quite impressive.

Source: BioXpress Therapeutics SA

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