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Date: 2015-09-03

Type of information: Product launch

Product name: EP2006 (Zarzio® - EU/Zarxio® - US

Compound: filgrastim - biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF)

Therapeutic area: Cancer - Oncology

Action mechanism:

biosimilar. protein

Company: Sandoz (Switzerland)

Disease:

neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever

patients with cancer receiving myelosuppressive chemotherapy;

patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;

patients with cancer undergoing bone marrow transplantation;

patients undergoing autologous peripheral blood progenitor cell collection and therapy;

patients with severe chronic neutropenia.

Latest news:

* On September 3, 2015, Sandoz, a Novartis company, announced that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio™ is the first biosimilar approved by the FDA and the first to launch in the US. The launch follows the FDA approval of Zarxio on March 6, 2015. The approval, via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio™ is highly similar with no clinically meaningful differences to the US-licensed reference product. The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio™ as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference product.

* On March 6, 2015, the FDA approved Zarxio® (filgrastim-sndz), the first biosimilar product approved in the United States. Sandoz’s Zarxio® is biosimilar to Amgen’s Neupogen® (filgrastim), which was originally licensed in 1991. Zarxio® is approved for the same indications as Neupogen, and can be prescribed by a health care professional for: patients with cancer receiving myelosuppressive chemotherapy;patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

* On January 7, 2015, Sandoz announced that FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the reference product’s (Amgen’s Neupogen®) label. The recommendation was provided after the presentation of a comprehensive package of nonclinical, clinical and post-marketing pharmacovigilance data which confirmed Sandoz’ biosimilar filgrastim is highly similar to the reference product. The pivotal clinical package included a pharmacokinetic and pharmacodynamics (PK/PD) study in healthy volunteers, which established bioequivalence, and a clinical efficacy and safety study in breast cancer patients which demonstrated the same clinical performance and safety as the reference product.The clinical package is also supported by a global program including five randomized, double-blind, single and multiple dose PK/PD studies in healthy volunteers to assess pharmacokinetic and pharmacodynamic equivalence between biosimilar filgrastim and Neupogen® and a European non-comparative clinical safety and efficacy study. Post-marketing pharmacovigilance data from countries outside of the US also contributed to the totality of evidence. If approved in the US, Sandoz proposes to market biosimilar filgrastim under the name Zarxio™.

* On July 24, 2014, Sandoz announced that the FDA has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).,The reference product - Amgen's NEUPOGEN® - is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. Under the brand name Zarzio®, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. Zarzio® is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share.

* On March 24, 2014, Sandoz announced that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin’s GRAN®). The product, which will be marketed as Filgrastim BS Injection 75 µg/150 µg/ 300 µg Syringe “Sandoz”, is the second Sandoz biosimilar to be approved in Japan. Filgrastim is used with certain cancer patients to accelerate recovery of infection-fighting white blood cells after chemotherapy (prevention of neutropenia) and is also used to stimulate mobilization of hematopoietic stem cells for collection and transplantation. Sandoz Filgrastim is approved in Japan for the same range of indications as the reference product GRAN and offers patients comparable quality, safety and efficacy combined with potentially greater cost-effectiveness for the healthcare system.

* On April 25, 2013, Sandoz has announced that it has filed an application with the Japanese health authority (PMDA) for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF). G-CSF, also known as filgrastim, is used with cancer patients to accelerate recovery from neutropenia afterchemotherapy, and it is also used to stimulate mobilization of hematopoietic stem cells for collection and transplantation. EP2006 has already been on the global market since 2009 and is now marketed in more than 40 countries around the world including Europe under the brand name of Zarzio®.

 

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2015-03-06

UE authorization: 2009-02-06

Favourable opinion UE:

Favourable opinion USA: 2015-01-07

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes