Biosimilar Filgrastim Recommended for Approval in US

Zosia Chustecka


January 07, 2015

A biosimilar version of filgrastim (EP2006, Sandoz/Novartis) has today been recommended for approval in the United States.

The new product is like a generic version of the brand-name filgrastim, marketed as Neupogen (Amgen), which had sales of more than $1 billion in 2014. However, "generic" is the term used when the drug is a chemical compound. These drugs are recombinant biological products, so the term "biosimilar" is used instead.

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously to recommend approval of the biosimilar filgrastim product for all the five indications that are already approved for Neupogen. Filgrastim is a recombinant human granulocyte colony-stimulating factor with several clinical uses, including aiding recovery from neutropenia in cancer patients undergoing chemotherapy.

Novartis already markets the biosimilar in Europe (since 2008) and in many other countries under the name Zarzio. The company said it intends to use the name Zarxio in the US if the product is approved by the FDA. The FDA often follows the recommendation of its advisory committee, but not always.

Today's decision has attracted much attention, as the product is considered to be the first true biosimilar to undergo approval scrutiny in the US since a new biosimilar regulatory pathway was introduced in February 2012.

According to a Bloomberg report, previous products were imitations of biologic drugs and not considered to be true biosimilars. One of these previously approved products was tbo-filgrastim (Granix, Teva), which was approved in August 2012. Although at the time of its approval, Teva said that Granix was biosimilar to Neupogen, several reports are now saying that Granix is not a true biosimilar. In addition, the Bloomberg report notes that it struggled to gain market share even though it was 30%-40% cheaper than its brand-name counterpart.

Today's meeting is "historic" for the FDA, the Generic Pharmaceutical Association (GPhA) said in a statement. "It is an important step forward for cancer patients and all who are awaiting access to more affordable versions of lifesaving biologic medicines here in the United States."

According to a report in the Wall Street Journal, Amgen has filed a lawsuit in a California federal court claiming that Novartis hasn't provided enough information to determine whether it is infringing on Amgen's patent. The newspaper suggests that this lawsuit could delay the potential launch of the drug.

No Clinically Meaningful Differences

In a document filed ahead of today's ODAC meeting, the FDA reviewers concluded that "there are no clinically meaningful differences in the effectiveness of EP2006 (the Novartis product) and US-licensed Neupogen for all of the five indications for which US-licensed Neupogen is approved."

This conclusion is also supported by efficacy results from a clinical trial, the FDA reviewers added: the EP06-302 study carried out in patients with breast cancer receiving TAC chemotherapy (Taxotere [docetaxel], Adriamycin [doxorubicin], and cyclophosphamide), which had a randomized comparison of EP2006 with US-licensed Neupogen.

The FDA reviewers concluded: "Taken together in considering the totality of the evidence, the data submitted by the applicant show that EP2006 is highly similar to US-licensed Neupogen and the clinical data have shown that there are no clinically meaningful differences between EP2006 and US-licensed Neupogen suggesting that EP2006 should receive licensure for each of the 5 indications for which Neupogen is currently licensed."

The prescribing information for Neupogen lists its five indications as follows:

  • cancer patients receiving myelosuppressive chemotherapy: Neupogen is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever

  • patients with acute myeloid leukemia (AML) receiving induction or consolidation chemotherapy: Neupogen is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML

  • cancer patients receiving bone marrow transplant: Neupogen is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae

  • patients undergoing peripheral blood progenitor cell collection and therapy: Neupogen is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy‚ the transplantation of an increased number of progenitor cells can lead to more rapid engraftment‚ which may result in a decreased need for supportive care

  • patients with severe chronic neutropenia: Neupogen is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia


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