Hikma wins right to market Roche drug copy in Middle East and North Africa

Hikma Pharmaceuticals Plc has won exclusive rights to distribute and market its third biosimilar drug - a copy of Roche’s blood cancer treatment Rituxanin - in the Middle East and North African markets, it said on Tuesday.

The Jordan-based drugmaker agreed to the licensing deal with Celltrion to market the South Korea-based biopharmaceutical firm’s Truxima, a copy of Roche’s blockbuster blood cancer medicine, also known as MabThera.

Truxima, the first biosimilar cancer drug to hit the European market in February, is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and microscopic polyangiitis.

Hikma, which makes and markets branded and non-branded generic and injectable drugs in more than 50 countries including Britain, has been hit by higher pricing pressures in the generic industry and has lowered revenue forecasts three times this year.

European drugmakers had been faced with increasing competition from cut-price copies of complex biotech drugs.

The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But a growing number of such drugs have now been approved in Europe as similar enough to do the job.

Truxima has been approved in all of Rituxan/MabThera’s indications and governments around Europe are keen to see it used widely, in order to curb rising drug bills.

Hikma is currently also in a dispute with the Food and Drug Administration over plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the U.S.