Sanofi is now compelled to revise its strategy as public advertising of Beyfortus (nirsevimab), an RSV preventive antibody injection, faces regulatory obstacles in Korea.

According to Dailypharm’s coverage, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Drug Advertising Review Committee ruled that Beyfortus is “not subject to advertising review.”

In South Korea, vaccines for the prevention of infectious diseases are classified as prescription drugs or over-the-counter drugs, and are allowed some advertising to the general public.

However, under the Regulations on Prior Review of Pharmaceutical Advertisements, vaccine advertisements must undergo prior review by the KPBMA’s Advertising Review Committee.

In effect, the KPBMA’s decision has made it difficult for Beyfortus to be advertised on TV or online to general consumers.

Beyfortus is an antibody injection that is administered once to all newborns and infants under 12 months of age to prevent RSV infection for at least 5 months, and it was approved by the Ministry of Food and Drug Safety in April last year.

Inoculation with Beyfortus began in domestic hospitals and clinics starting in early February and has been administered to infants and young children, and is now being approved by drug committees in general hospitals as well.

Sanofi has been working to raise awareness of RSV disease with the launch of its product. A representative example is the “RSV Story Contest,” which aims to collect and share experiences about the disease.

However, in the case of Beyfortus, the company will face limitations in building brand awareness and expanding market reach through public advertising, which is the most straightforward way to promote the product.

 
The current Pharmaceutical Affairs Act imposes strict regulations on advertising for prescription drugs. According to Article 68, Paragraph 6 of the Pharmaceutical Affairs Act, prescription drugs, except for vaccines, may only be advertised in specialized media or academic journals targeting medical and pharmaceutical professionals.

Public media advertising is exceptionally permitted for vaccines used for preventive vaccination, but public advertising for other prescription drugs is prohibited. Beyfortus is approved for preventive purposes, but as it was approved as an antibody drug, not a vaccine, it is not covered by this exception.

The advertising ban has caused quite a stir. First, the company now has an urgent need to raise awareness of the product through other means.

Normally, when a new vaccine is released, a large-scale vaccination campaign is launched through TV commercials and online promotions, but this is rendered difficult for Beyfortus.

In addition, existing premium vaccines have employed strategies such as using celebrities as models to naturally promote specific vaccines as “OOO vaccines,” but this has also become difficult.

In other words, Sanofi, which wanted to promote Beyfortus in the domestic market through advertisements, will inevitably face restrictions on its future marketing strategies.

As a solution, Sanofi is expected to shift its sales and marketing focus to medical professionals, akin to the prescription drug market.

With general consumer advertising blocked, Sanofi is likely to prioritize product promotion through medical professional channels such as academic conferences and symposia. This is an indirect marketing approach that aims to increase consumer awareness through indirect promotional activities centered on departments such as pediatrics, obstetrics and gynecology, and infectious diseases.

In fact, it is rumored that several obstetrics and gynecology hospitals have already begun recommending Beyfortus vaccinations to parents of newborns.

In this regard, Sanofi is still awaiting the results of KPBMA’s preliminary review.

A Sanofi official stated, “The possibility of advertising Beyfortus to the general public is currently under review by the KPBMA, and we are awaiting the results of the review.”