Filgrastim stimulates the production of neutrophils, a type of white blood cells important in the body’s fight against infection. One treatment option for individuals with certain types of cancers is myelosuppressive chemotherapy which targets rapidly dividing tumor cells. Since rapidly dividing normal cells, such as bone marrow precursor neutrophils are also vulnerable to the cytotoxic effects of myelosuppressive chemotherapy, lower numbers of neutrophils are produced, a condition called neutropenia, which increases the risk of severe infection. Amgen launched filgrastim, under the Neupogen brand, in 1991 to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Since Amgen’s principal European patent related to filgrastim was due to expire in August 2006, the company launched a long acting formulation, a pegylated filgrastim (pegfilgrastim), under the brand name Neulasta in 2002. The move, part of Amgen’s product lifecycle management strategy, resulted in Neulasta replacing Neupogen in major treatment centers. Amgen’s US patent for Neupogen expires in December 2013. Although Neulasta’s patent does not expire until December 2015, the launch of generic competition could adversely affect sales of both brands.
Teva is a serious player in the international biosimilars market. Teva also has two long acting filgrastim formulations in late stage development. In August 2012, the FDA approved Teva‘s (TEVA) Neutroval (tbofilgrastim). The approval, which was based on a full Biologic License Application (BLA) rather than under the FDA’s new biosimilar approval pathway, would allow Teva to compete directly with Amgen‘s (AMGN) US filgrastim franchise, worth $4.2 billion at the end of 2012. However, due to a court ruling related to Amgen’s filgrastim patents, Teva may not start selling its product in the US until the 10th of November 2013, in just six weeks’ time. Read More: Seeking Alpha