The US Food and Drug Administration has accepted Sandoz’s biologics license application (BLA) under the 351 (k) pathway , the US regulatory pathway for biosimilars, for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, part of Novartis, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases, including rheumatoid arthritis and psoriasis.

This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. Earlier this year, Sandoz received FDA approval for Zarxio (filgrastim-sndz), the first biosimilar product approved in the US. Zarxio is based on the reference product, Neupogen, marketed by Amgen, which was originally licensed in 1991. Zarxio was approved for the same indications as Neupogen and can be prescribed by a healthcare 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.

In the US, the regulatory pathways for biosimilars was authorized by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was passed as part of the Affordable Care Act that was signed into law in March 2010. The BPCIA 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.

Sandoz’s BLA for a biosimilar of etanercept consists of a data package that includes data from analytical, functional, pre-clinical, and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic study in healthy volunteers and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis, will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.

Sandoz has a several biosimilars across the various stages of development, including five programs in Phase III clinical trials or registration preparation. The company plans to make ten regulatory submissions in the next three years.. Sandoz currently markets three biosimilars (somatropin, filgrastim, and epoetin alfa) outside the US.

Source: Sandoz