by 2022, 30 out of the 50 top drugs will have some form of outcomes‐based contracts in place between pharmaceutical manufacturers and payers.32
Biosimilars, which are similar versions of innovator biologic drugs, are expected to generate cost‐savings compared to the innovator/reference brand that they compete with. The adoption of biosimilars in the United States has been relatively slow compared to other developed markets like the European Union. It is expected that the adoption of biosimilars in Europe will continue to outpace the United States for the upcoming decade; however, major events are on the horizon in the United States including the introduction of the first biosimilars to Humira®, currently the world's top‐selling drug.32 A concerted effort by countries and payers across the globe to educate prescribers and patients on the safety and efficacy of biosimilars will be required to see similar type of savings that small molecule generics generate today.
3.6 Summary
Considering the complexities associated with developing, manufacturing, administering, and paying for biologic drugs, a fundamental question is why the science of drug discovery is moving away from small molecule drugs to biologics? In short, because there is no better alternative that is currently available. In the ongoing development of safer and more efficacious drugs, biologics are the logical next step and this will continue to be the case in the foreseeable future. Most human diseases are caused by signaling imbalances, which involve numerous protein–protein interactions. Biologics afford the capability to alter such complex signaling systems in ways that small molecule drugs, to date, have not been able to. It is estimated that of ~20 000 human proteins, only about 3000 can be regulated by small molecule drugs.34
The treatment spectrum of biologic therapeutics is broad. They can limit pro‐inflammatory cytokines that erode synovial tissue in rheumatoid arthritis, stimulate red blood cell production in kidney disease, replace the deficient insulin in diabetes, or influence the body to attack cancer using the natural immune system. The umbrella term, biologics, includes the gene therapies used to treat and/or cure diseases that have had little to no treatment options currently. R&D of gene therapies will continue in the upcoming decade and will provide the opportunity for potentially curing certain diseases.
It will be incumbent upon pharmaceutical manufacturers and payers to strike a balance that ensures continued innovation is affordable and accessible on a global scale. Rare diseases that result in dismal health outcomes require therapies that do not exist today and, in many cases, treatment options that exist for diseases today can also be dramatically improved. Precision medicine, including the improved identification of biomarkers and a better understanding of pharmacogenomics, will be one pathway toward finding the nexus of cost‐effectiveness and value. While biologics will not cure all diseases or solve all health problems, they will be an integral part of drug therapy in the foreseeable future.
References
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