AstraZeneca Korea has recently sent proof of content notices to several Korean companies that have launched generic versions of their diabetes treatment drug, Farxiga. The reason behind this action is that these companies have been promoting their generics with indications that have not been approved for Farxiga.

Farxiga, which contains the active ingredient dapagliflozin and belongs to the SGLT2 inhibitor class, has received approval from the South Korea Ministry of Food and Drug Safety(MFDS) for three indications: Type 2 diabetes, chronic heart failure, and chronic kidney disease. However, after the patent for Farxiga expired on April 7th, Korean pharmaceutical companies started marketing generics specifically for the indication of Type 2 diabetes, based on remaining patents and specific approvals obtained during the regulatory process.

The proof of content by AstraZeneca Korea is in response to the inclusion of unapproved indications for Farxiga generics in the marketing materials of these companies. One domestic pharmaceutical company, referred to as Company A, included messages in medical journals implying that their generic product can be safely prescribed without concerns about kidney and heart-related issues. Similarly, Company B used graphics that could evoke associations with heart-related conditions, and Company C included information in their internal training materials suggesting effective results in kidney and heart conditions. Sales representatives of these companies were reportedly utilizing this information in the field.

Upon receiving the proof of content notices, the companies have taken measures to rectify their promotional materials. They have recalled brochures and modified the design of previously used materials. Some companies have even added captions clarifying that the clinical results mentioned were obtained with Forxiga, not with the generics.

The regulatory authority has declared that advertising by generic manufacturers, claiming to have the same approved indications as Farxiga, violates the Pharmacy Act. Article 68 of the Pharmacy Act explicitly prohibits the advertising of pharmaceutical products' efficacy or performance unless approved or modified approval has been obtained.

With the official stance of the MFDS, the controversy between AstraZeneca and the generic companies in the Korean Farxiga market is expected to continue in the foreseeable future.