The best-selling prescription in America may soon face increased competition, raising hopes of lower prices and more innovation.
Adalimumab is the best-selling drug of all time. The injectable biologic is approved to treat autoimmune conditions including arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Now the introduction of as many as eight competitors presents an ideal test case to see if the competitive forces in pharmaceutical markets can enhance affordability and improve patient choice.
Biosimilars are FDA-approved alternatives to innovator biologics.
Biologic medicines are compounds made from living organisms. This means they are not manufactured from mere molecules but from living cells. Unfortunately, biologics are typically quite expensive: Comprising just 2% of all prescriptions, they account for 40% of all spending.
Increasingly, though, less-expensive versions of biologics known as biosimilars are coming to market. These, the FDA says, have “no clinically meaningful differences” from biologics.
Experts point to 2023 as a critical moment for biosimilars. At least eight more are expected to debut this month, marking what some have called a “biosimilar boom. Many may next seek interchangeable status from the FDA, which allows pharmacists to substitute a less-expensive treatment without involving the prescribing physician.
Insurers and pharmacy benefit managers could keep potential patient savings as profits.
When marketed, these biosimilars could test key elements of the approval and prescription benefit system.
One of the most pressing concerns is whether the lower costs of competing biosimilars will be realized as savings by patients. It’s possible that insurers and pharmacy benefit managers could capture much of those savings as profit, leaving the prices paid by patients largely unchanged.
Policymakers are keeping a close eye on the approval, adoption and reimbursement of biosimilars, as one means to provide more affordable and effective treatment for all patients.
