Novartis announced it has filed a Citizen Petition with the U.S. Food and Drug Administration (FDA), urging the Agency to require that a biosimilar share the same INN as the reference product.
Novartis argues that changing the well-established convention that the INN describes the active ingredient would undermine the safe and rational use of all biologics. In its petition, the company also highlights that “assigning different INNs to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk, or other regulatory reservations that are purely hypothetical.”
The main points addressed in the Novartis Citizen Petition include:
- INNs are not designed to identify a specific product or track adverse events. INNs were designed to indicate active pharmaceutical substances, not a specific product. They were also never intended to identify or track individual products; there is already a robust drug safety system in place – to report adverse events – for tracking and tracing. The current system identifies each biologic by brand names, National Drug Code (NDC) numbers and manufacturer.
- Changing the naming convention would undermine FDA’s years of practice in reviewing and approving manufacturing changes of originator biologics without requiring new INNs. Requiring separate INNs for biosimilars but not originator biologics would undermine FDA’s own approval decisions, which in both cases require FDA to determine that the compared product produces the same effect as its comparator.
- An inconsistent application of naming conventions would lead to medication errors and jeopardize patient safety. Unique INNs for biosimilars would lead to confusion and encourage prescribing by INN. Current prescribing is by brand names with each brand name having been vetted for distinctiveness and clarity by FDA. FDA discourages the use of prefixes or suffixes in brand names because they are known to risk confusion and medication errors.
“Practitioners around the world have relied on the present naming convention for over 50 years, and the introduction of biosimilars does not warrant a change in this policy,” said Mark McCamish, head of Global Development Biopharmaceuticals & Oncology Injectables at Sandoz. “As a leader in both innovative and generic medicines, we believe that a modified INN would thwart patient access and prevent the U.S. from receiving the full cost-saving benefits of biosimilars enjoyed in Europe and other highly-regulated markets.”
Since 1953, the World Health Organization (WHO) has administered the INN system, which groups drugs and biologics according to their active pharmaceutical ingredients. This system has been successfully used with biosimilars in highly-regulated markets across the globe, including Europe.
Novartis recognizes that the introduction of generic or follow-on medicines after patent expiration stimulates innovation within the industry, provides cost savings to the system, and increases patient access to critical medicines. Novartis, through Sandoz, its generic pharmaceutical division, is the pioneer and global leader in biosimilars, with over 50 percent share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience.
Date: October 31, 2013
Filed Under: Drug Discovery