GPhA meets with FDA over biosimilars naming

March 14, 2014 11:03 AM

GPhA had a meeting with FDA in January this year about biosimilars naming and the memorandum of this meeting has been published publicly recently.

The meeting was held with the attendance of David Gaugh, RPh, Senior Vice President for Sciences and Regulatory Affairs from GPhA and several representatives from FDA.

GPhA requested this meeting to discuss the dialogue held at a recent World Health Organization (WHO) meeting regarding nonproprietary names of biosimilars and the possible addition of identifiers to the nonproprietary names of innovator biological products to name biosimilar products. These issues relate to a citizen petition submitted by GPhA, which was pending with FDA as of the date of the meeting. FDA stated that it was open to meeting with GPhA, but it would be a “listening session”.

During the meeting which was held on January 9th, GPhA stated that the position outlined in its September 17, 2013 citizen petition has not changed. GPhA believes that adverse events can be traced back to the biological product involved through the five data points it has outlined previously without the need to change the nonproprietary name. Although it is GPhA’s understanding from conversations with individual FDA employees that FDA cannot require sponsors to designate a brand name (proprietary name), GPhA and its members would commit to use of a brand name for biological products.

According to GPhA, at the recent WHO meeting on INN, the WHO INN Expert Committee discussed adding a specific identifier to the INN of biosimilar products. This may be the abbreviation BQ (which stands for biologic qualifier) plus 3 random alphanumeric characters. This identifier may be connected to the INN, such as with a hyphen, but would not be considered part of the INN.

GPhA indicated that it is discussing this proposal with its member companies and others, and noted that the random alphanumeric characters of the WHO/INN proposal would not function to directly identify the manufacturer. Accordingly, GPhA also is considering an alternate proposal that would distinguish between products by attaching the company name as a suffix to the INN without changing the INN. If an identifier is to be attached to the INN of a biosimilar product, GPhA opined that such an identifier should be attached to the innovator biological product as well (e.g., “filgrastim Amgen”). GPhA believes that this proposal would provide “distinguishable” and “immediate identification.” However, GPhA noted its position that this proposal still could have an effect on patient safety, access, and affordability of biological products.

GPhA noted that in the Amgen comment on the GPhA and Novartis citizen petitions and in the recent citizen petition submitted by Johnson and Johnson (J&J), Amgen and J&J assert that the products should have “distinguishability.” GPhA stated that it does not disagree with “distinguishability,” but believes that this can be done without changing the INN.

 

Source: http://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0077-0006

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