AMGN » Topics » Competition

This excerpt taken from the AMGN 10-Q filed May 11, 2009.


Certain of our marketed products are under increased competitive pressures, including from biosimilar and other products in Europe, which compete or are expected to compete with Aranesp®, Neulasta® and NEUPOGEN®, as well as our marketed products in the United States, including ENBREL. For example, we have experienced and expect to continue to experience increased competition throughout Europe, including from a number of biosimilar erythropoietin products, which compete with Aranesp®. In addition, a number of G-CSF biosimilar products have received or are expected to receive marketing authorization from the European Commission, and have been or are expected to be launched and compete with Neulasta® and NEUPOGEN®. Further, in the United States, ENBREL will continue to face increased competition primarily due to the expected launch of new products, including competition from J&J’s Simponi TM (golimumab), which was approved by the FDA in April 2009.

This excerpt taken from the AMGN 10-Q filed Nov 7, 2008.




On October 17, 2008, the Massachusetts District Court entered judgment that the patents in suit are valid and enforceable, and would be infringed by the import, use and sale of Roche’s pegylated-erythropoietin product. The Massachusetts District Court permanently enjoined Roche from infringing the ‘422 patent, the ‘933 patent, the ‘868 patent and the ‘698 patent for the remaining life of these patents.



On September 15, 2008, Ratiopharm’s Ratiograstim®/Filgrastim Ratiopharm®, CT Arzneimittel’s Biograstim® and Teva Generics (“Teva”) Tevagrastim®, all G-CSF biosimilar products, received marketing authorization from the European Commission. Ratiopharm launched its G-CSF biosimilar product, Ratiograstim®, in the United Kingdom in October 2008, and is expected to launch it in Germany and several other European markets in the fourth quarter of 2008. CT Arzneimittel is expected to market its G-CSF biosimilar product in Germany in the fourth quarter of 2008. Teva stated that it would begin marketing its G-CSF biosimilar product throughout Europe in 2009.


May 11, 2009
Nov 7, 2008
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