Biosimilars are structural imitations of the originator, whereas biobetters are improvements to the originator biological molecule. While biosimilars promise the same effect at a reduced price, a biobetter will possess some molecular or chemical modification that constitutes an improvement over the originator drug and its biosimilar competitors.

The improvement in this case is not in the drug, but in the complex polysaccharide coating attached to it. The carbohydrate chains attached to the antibodies serve various functions. For instance, some proteins do not fold correctly unless they are glycosylated first. Other drugs are quickly degraded unless protected by glycosylation. Glycosylation may also play a role in cell–cell adhesion, a mechanism employed by cells of the immune system.

Glyco-optimised TrastuzuMab-GEX (TrasGEX)

TrasGEX is the name of the biobetter antibody. A significantly better therapeutic outcome is promised for all patients eligible for trastuzumab treatment. It is hoped that the fully human nature of TrasGEX’s host cell lines will also avoid the common immunogenic reactions against host-derived non-human components.

Announcing enrolment of the first patient in the phase I trial on 19 September 2011, Glycotope CEO and Founder Dr Steffen Goletz said that, after CetuGEX and PankoMab-GEX, TrasGEX is their third anticancer antibody to enter clinical trials. ‘Our glycol-optimised Follicle-Stimulating Hormone FSH-GEX has already completed clinical phase IA with very exciting results,’ Dr Goletz said.

About Glycotope

Glycotope, founded in 2001 in Berlin, Germany, focuses on the optimisation and humanisation of therapeutically relevant sugar structures on biopharmaceuticals, known as glycosylation This not only leads to important therapeutic benefits for a significantly increased number of patients, in addition, the GlycoExpress platform is superior in production yields, product quality and reproducibility compared to other production platforms.

Together with Glycotope Biotechnology in Heidelberg, Germany, Glycotope has evolved into a leading integrated glycobiology company, covering all phases in drug development such as lead discovery and optimisation, preclinical and process development, good manufacturing practice production and clinical development. With more than 140 employees, the group has grown to one of the largest biotech organisations in Germany.

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