Eye on Pharma: Hikma Reaches Rituximab Licensing Agreement With Celltrion

Hikma Pharmaceuticals Plc. announced yesterday that it has reached a licensing agreement with Republic of Korea-based Celltrion for its rituximab biosimilar, Truxima, referenced on MabThera. Hikma, based in Jordan, now has exclusive rights from Celltrion to market 3 biosimilar products, rituximab (Truxima), infliximab (Remsima), and trastuzumab (Herzuma) in all of the Middle East and North African (MENA) markets.

Truxima was the first biosimilar anticancer therapeutic to hit the European market in February 2017. Truxima, like the reference rituximab, which is sold in the European Union as MabThera (and as Rituxan in the United States), is used to treat patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and microscopic polyangiitis, among other indications.

Mazen Darwazah, vice chairman and CEO of MENA and Emerging Markets said, “We are pleased to be adding Truxima to our biosimilar and oncology portfolio, building on the success of our partners with Celltrion in the MENA region. Global partnerships are an integral part of our strategy to enhance our portfolio in key therapeutic areas and increase patients’ access to high-quality, affordable medicines.”

The Jordan-based company boasts a product portfolio of over 700 products across key therapeutic areas. Hikma makes and markets branded and non-branded generic and injectable drugs in more than 50 different countries. Yet the company has been hit by higher pricing pressures in the generic industry, and has lowered revenue forecasts 3 times this year alone.

Hikma is also currently in a dispute with the FDA over plans to launch a generic copy of GlaxoSmithKline’s popular drug Advair in the United States. The root of the issue is the team’s clinical endpoint study, according to Hikma, which says it “firmly” disagrees with the FDA’s concerns. With Hikma in a potentially lengthy delay, Novartis’ Sandoz could be the uncontested first-place winner in the race to bring a generic of the respiratory blockbuster to the market.