US-based Hospira has entered into an agreement with South Korea's Celltrion to develop and market eight biosimilars. The companies will independently commercialise the products under their own brand names. Given Hospira's expertise in generic injectables and Celltrion's experience in biotechnology-based contract manufacturing, BMI expect the collaboration to be successful. However, we note that many other companies are already present in the biosimilar sector and that competition is increasing rapidly.
It is BMI's view that South Korea will emerge as a global leader in biosimilar research and development. In July 2009, the local electronic giant Samsung announced that it would spend US$389mn on biosimilars over the next five years. The Korean Food and Drug Administration introduced a biosimilar regulatory pathway earlier this year. Most recently, a South Korean clinical trial of a biosimilar version of Amgen and Wyeth's Enbrel (etanercept) was completed successfully.
The deal with Hospira will facilitate Celltrion's ambition to become a top-ten biopharmaceutical company. The South Korean firm was established as a joint-venture between a group of local investors and US-based VaxGen to produce biologics using mammalian cell cultures. As part of a deal with Bristol-Myers Squibb, Celltrion currently makes Orencia (abatacept), which is indicated for rheumatoid arthritis, and the investigational agent belatacept - a fusion protein for the prevention of tissue rejection following kidney transplant.
Earlier this month, Hospira acquired the global rights to Teva Pharmaceutical Industries' biosimilar filgrastim, which was being developed as part of a strategic collaboration with Pliva/Barr Pharmaceuticals (now owned by Teva). Applications for marketing authorisation for the biosimilar were filed in the EU and Australia in Q109. As part of the agreement, Hospira has also acquired process development capabilities and a manufacturing plant in Croatia with the capacity to meet global filgrastim production, as well as future requirements for pegfilgrastim and other biosimilar products.
Spun-out from Abbott Laboratories in 2004, Hospira is the world's largest manufacturer of generic versions of injectable drugs. It employs 16,000 people and has 19 production facilities. In 2008, the company recorded sales of US$3.63bn, a 5.6% increase compared with the previous year.