aHUS Trials Watch 7

News announced  in recent days that, unlike in the USA , Europe does not intend to extend the patent for Eculizumab when it expires in 2020.The US patent is to continue until 2027.

Loss of patent will expose Alexion to competition from biosimilars to eculizumab in Europe.

Such competitive drugs will themselves take time to be trialed, tested and approved before they can be available to patients from 2020 onwards.

The alliance noticed this trial recently announced about a  substance called  SB12- a biosimilar of eculizumab.

Designed by Samsung Bioepis Co. Ltd. the trial location  is named as Berlin Germany. The principle Investigator being Dr  Rainard Fuhr

240 participants are being sought to receive a single random  300mg dose of the biosimilar or eculizumab and the  pharmokinetics , Safety, Tolerability, Immunogenicity and pharmacodynamics of the drugs will be compared..

The biosimilar will not be used as a treatment of aHUS patients, that would only happen in later trial phases if early trial stages are successful.

More information about this trial can see seen HERE

Alexion is believed to appealing against the decision. It is also looking to switch patents to Ultomiris , its longer lasting version ravulizumab.