Affordable mRNA Novel Proteins, Recombinant Protein Conversions, and Biosimilars—Advice to Developers and Regulatory Agencies

mRNA technology can replace the expensive recombinant technology for every type of protein, making biological drugs more affordable. It can also expedite the entry of new biological drugs, and copies of approved mRNA products can be treated as generic or biosimilar products due to their chemical nature. The introduction of hundreds of new protein drugs have been blocked due to the high cost of recombinant development. The low CAPEX and OPEX associated with mRNA technology bring it within the reach of developing countries that are currently deprived of life-saving biological drugs. In this paper, we advise developers to introduce novel proteins and switch recombinant manufacturing to mRNA delivery, and we further advise regulatory authorities to allow for the approval of copies of mRNA products with less testing. We anticipate that mRNA technology will make protein drugs, such as natural and engineered proteins, monoclonal antibodies, and vaccines, accessible to billions of patients worldwide.