Biosimilar mRNA vaccines, approved under 351(k) or a modified 351(a), can fulfill the present and future needs of accessible life-saving vaccines across the globe.
The road to production of biosimilar messenger RNA (mRNA) vaccines could be very swift compared with the experience for other biologics. With fewer intellectual property restrictions, small manufacturers could step right in, according to Sarfaraz K. Niazi, PhD.
In my first article on the topic, I created a new term, “biosimilar mRNA vaccine,” to suggest that chemically synthesized messenger RNA (mRNA) vaccines can be approved as biosimilars under the 351(k) provision by the Center for Drug Evaluation and Research (CDER) rather than as standalone or “novel” 351(a) drugs under the Center for Biologics Evaluation and Research (CBER).
However, there are pros and cons to both pathways to approval. In the biosimilar pathway, a 12-year exclusivity protection will apply if the reference vaccine is revised to address new mutations. This would require biosimilar developers to file a new biologics license application (BLA).
The analytical similarity testing can also be challenging depending on which is considered the active ingredient: the mRNA or the translated protein. In a standalone approval, complete testing will take a longer time and cost. However, given the recent guideline on COVID-19–related products, the FDA is willing to consider standalone filing with the same concessions as are allowed in the filing of biosimilar products. It remains to be seen how the first product filing will be treated.
Today, the world needs about 8 billion doses to create herd immunity worldwide; the WHO and other global agencies are urging that vaccines be supplied to countries that could not afford the cost of the first wave of COVID-19 vaccines. Although there is a surplus of vaccines in the United States, 75% of the world’s population is still waiting for shots. To meet this challenge, we will have to develop a novel pathway to secure faster entry into the market for the COVID-19 mRNA vaccine.
In this article, I present a path that manufacturers could follow for quick access to the market (Figure). To make the best use of the available technology, a creative and well-organized approach is required:
Biosimilar mRNA vaccines, approved under 351(k) or a modified 351(a), can fulfill the present and future needs of accessible life-saving vaccines across the globe. The original developers are not able to offer these products at an affordable cost for many reasons, including their capital investment and their need to show a robust profit because they are publicly traded companies. Since the dose of the vaccine is minimal, the production costs are also low. If the cost of an amount provided as bulk is about $0.68 and sold at $3 per dose, it can generate an income of billions of dollars. Still, the reference vaccine producer will not enter these markets, or else they will lose their most profitable business, supplying to richer countries at almost 10 times the price they would get from developing country patients.
Biosimilar mRNA vaccines, approved under 351(k) or a modified 351(a), can fulfill the present and future needs of accessible life-saving vaccines across the globe.
Most people in the poorest countries will need to wait another 2 years before being vaccinated against COVID-19. Around 11 billion doses are required to fully vaccinate 70% of the world’s population against COVID-19. However, the most effective mRNA vaccines are not going to be available to developing countries. Pfizer has cautioned its investors that the rewards of producing a vaccine for low-income and mid-income countries will be nonexistent to very low. The position taken by Pfizer is in stark contrast to Moderna, which has allowed the use of its pending intellectual property (patents). However, with intervention from the US government and the World Trade Organization, Pfizer will allow the use of the IPs if the intent is to distribute these vaccines to the developing countries.
Therefore, I am encouraging companies to consider this remarkable opportunity to help in ending this pandemic and saving millions of lives.
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