In response to US biotechnology firm Amgen's April 11 filing with the US International Trade Commission in Washington DC, the agency has decided to institute an investigation of Roche's importation of pegylated recombinant human erythropoietin (peg-EPO) into the USA. Amgen is asking the ITC to issue a permanent exclusion order that would prohibit importation of peg-EPO into the country.
The ITC is an independent federal agency that protects US companies and industries from unfair trade practices. Amgen anticipates the investigation will proceed over the normal course of the next several months.
Amgen believes that an investigation by the agency is an appropriate step towards ensuring fair competition in the USA, saying: "we believe Roche's peg-EPO violates six of our US patents and does not provide any additional clinical or patient benefit over Amgen's innovative therapies, Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).
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