Description: The big event of 2023 is the launch of multiple Humira biosimilars, which began in January with the arrival of Amgen’s Amjevita on the market. The launch of Amjevita kicks off the process of changing the specialty drug marketplace in the United States. The expectation of the full impact of this big event is very hopeful, but there is still uncertainty several months after its beginning. Humira is the highest-selling drug in the world and has been since 2013 (Figure 1)—except for when COVID-19 projects temporarily surpassed it. The world is eagerly awaiting the launch of multiple biosimilar drugs to compete with Humira and hopefully bring more competitive pricing to the benefit of payers and patients everywhere.

Description: Savings from biosimilars have accelerated significantly in the past few years. There has been a number of relatively recent biosimilar launches that can help to shape our expectations of the financial impact that could result from this year’s big event. Savings from biosimilars have accelerated significantly in the past few years. There has been a number of relatively recent biosimilar launches that can help to shape our expectations of the financial impact that could result from this year’s big event.

Description: PBMs are positioned in the healthcare delivery system as the only entity that is not regulated for profitability. The Commercial Fully Insured Health Insurance Plans are heavily regulated by the State Insurance Commissioner who allows only 2%-3% profit margin. The self-funded Health Plans are regulated by ERISA fiduciary responsibility that prohibits excessive compensation. PBMs are classed as a service provider and are not regulated by either. This allows PBMs to implement large, unreasonable mark ups for profit. PBMs are massive commercial entities, states are trying to sue under antitrust law. PBMs found a sweet spot in the regulation. Large Insurance Carries understood that and either acquired large PBMs or merged with them. It is likely that a combination of measures will be needed to regulate PBMs. The most direct approach would be for Congress to pass a law establishing PBM as a fiduciary under ERISA just like an “investment advisor” providing advice for a fee. Establishing PBM as a fiduciary will help Courts and other Federal Agencies ensure that PBMs do not unfairly retain rebates and inflate the prices of Rx drugs sold to employer health plans, and the US population in general.