Falsified rare disease drug Soliris found in supply chain

Phil Taylor, 13-Jan-2022

Several falsified batches of a medicine claiming to be AstraZeneca/Alexion's rare disease therapy Soliris were discovered in the supply chain in the last few weeks of 2021, according to the World Health organization (WHO).

Various counterfeit copies with different packaging were found in South America, Europe and India, suggesting that there has been a concerted effort by fraudsters to inveigle the fake vials into international supply chains.

Genuine Soliris (eculizumab) is a complement C5 inhibitor used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

It is one of AZ's biggest products with sales of more than $4 billion in 2020, thanks in part to an annual price tag of more than $400,000.

The drug is administered intravenously, so administration of the fake medicines could put patients at serious risk of blood infections if the vials have not been filled and kept in sterile conditions, toxicity from unknown ingredients, and loss of treatment efficacy.

Falsified copies of the Soliris with the lot number 1012401 and an expiry date of SEP 22 and Spanish packaging have been encountered in Argentina and Uruguay, with another version (Lot No. 1013715, Expiry Feb 2022) also found in Uruguay.

Another lot (No. 1001600, expiry 03/2023) was intercepted in Estonia with English packaging, while in India the batch is in the Turkish language and has the lot number 1001701 and expiry date of 03/2023.

WHO said in an alert that the suspect batches have been "confirmed as falsified on the basis that they deliberately/fraudulently misrepresent their identity, composition or source."

It's not the first time that counterfeit Soliris has been found in the supply chain. In 2018, Argentina's regulatory authority ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica said it had discovered two suspect batches of the drug.