FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act


Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins. A biosimilar is best characterized as a similar but not identical copy of a biologic that has previously been granted marketing authorization by the FDA. Minor differences between a biosimilar and a biologic may exist and are likely most often due to the variation in the processes used in their manufacture and are permitted so long as any differences are demonstrated not to be clinically significant.

The Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010 as part of the Patient Protection and Affordable Care Act and amended the Public Health Service Act (PHSA) to establish an expedited pathway for FDA approval of biosimilars (often referred to as “follow-on biologics”). This expedited pathway requires an applicant to submit an application containing detailed information about their biosimilar, including analytical studies showing that their biosimilar is highly similar to a branded biologic already approved by the FDA; animal studies that include an assessment of toxicity; and a clinical study or studies demonstrating the safety, purity, and potency of the biosimilar. Such requirements have been the subject of several guidances from the FDA intended to provide recommendations to applicants on the scientific and technical information of the chemistry, manufacturing, and controls (CMC) section of a marketing application for a proposed biosimilar product submitted under section 351(k) of the PHSA. Additionally, the BPCIA sets forth a detailed procedure and timeline where a holder of a branded biologic and a biosimilar applicant are to engage in a series of exchanges of information with the goal of determining which if any of the brand holder’s patents will be litigated by the parties. To date, this expedited pathway for FDA approval of a biosimilar has yet to yield any approved biosimilars.

On July 24, 2014, over four years after the enactment of the BPCIA, the FDA accepted its first biosimilar application from Sandoz Inc. (“Sandoz”). Sandoz’s application is for a biosimilar version of Amgen Inc.’s (“Amgen”) Neupogen® (filgrastim). Neupogen® is a pharmaceutical analog of human granulocyte colony stimulating factor that is used to treat neutropenia, a condition where the body does not make enough neutrophils, a type of white blood cell. Amgen’s Neuprogen® is indicated for use by patients receiving strong chemotherapy to reduce their risk of infection.

Sandoz’s biosimilar application is set to provide future applicants a wealth of information and, most importantly, with clarity around the FDA review process. For example, as part of filing its application, Sandoz will be required to engage in an exchange of manufacturing information with Amgen to resolve which, if any, of Amgen’s patents that cover Neupogen® will be litigated by the parties, and which, if any, patents will not be litigated by the parties. As the first biosimilar application to be subjected to these procedures, it will be interesting to see how the information exchange between Sandoz and Amgen plays out and what, if any, litigation arises as a result. Additionally, if Sandoz’s application is approved, it should provide clarity regarding the appropriate naming convention to use for biosimilars. Currently, there is an ongoing debate as to how biosimilars should be named. Branded biologic holders often assert that biosimilars should have distinct generic names; whereas, the biosimilar holders often assert that having distinct names will confuse patients into thinking that the biosimilar is not as safe or effective as the branded biologic. Further, the timeliness of the FDA’s decision on Sandoz’s application will indicate whether it will be possible for the FDA to meet its goal of reviewing 70% of new applications within 10 months for fiscal year 2014, as set forth in the FDA’s Biosimilar Biological Product Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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