Fake Soliris and several other knock-offs found in Argentina

Two counterfeit batches of Alexion’s rare disease therapy Soliris are among a slew of fakes found this month in Argentina, according to the company’s health authority.

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) says (PDF) the two suspect batches are of Soliris (eculizumab) 300mg/30mg concentrate for solution for infusion vials and have the lot numbers P0004906 and P0004907, both with an expiry date of 03/2019.

Soliris has been approved to treat blood disorders paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS) and myasthenia gravis, and is imported for compassionate use in Argentina, according to ANMAT. It is known to be one of the most expensive drugs on the market with an annual price tag of more than $400,000.

Soliris was first approved in the US in 2014 and and has become a blockbuster brand, with sales of around $3bn in 2017.

Also this month, ANMAT has also warned that it had encountered counterfeit versions of the following drugs:

- Teva’s multiple sclerosis therapy Copaxone (glatiramer acetate) 40mg/ml; 12 prefilled syringes (Lot number C42234, Expiry 04/2018);

- Novartis’ for chronic myeloid leukaemia Tasigna (nilotinib) 200mg capsules x 112 (Lot SF432, Expiry 06/2019);

- Roche’s cancer drug Avastin (bevacizumab) 400mg/16ml vial x 1 (Lot H179810 VEN, Expiry 02/2018); and

- ViiV Healthcare’s HIV drug Kivexa (abacavir/lamivudine) 30 coated tablets (Lot KC7W, Expiry 10/2019);

- Merck & Co’s HIV treatment Isentress (raltegravir) 60 x 400mg film-coated tablets (Lot ARG0324/L026309, Expiry Apr/2018);

- Roche breast cancer therapy Perjeta (pertuzumab) 1 x 420mg/14ml vial (Lot H0109918, Expiry 10/2019;

- Laboratorios Richmond SACIF’s Virorrever (efavirenz) 30 x 600mg coated tablets (Lot MEG35IK4, Expiry 02/19).