January 31 is set to mark the start of a watershed year for the biosimilars industry with the release of Amjevita, the first biosimilar for Humira, the world’s best-selling drug. Several more Humira biosimilars will also be released this year.
But without support from regulators and policymakers to make all biosimilars available on formularies, the full promise of these price-cutting drugs could be lost, costing the U.S. health care system $133 billion in the next three years.
It has been eight years since the FDA approved the first biosimilar in the United States. To date, 40 biosimilars have been approved in the United States after rigorous evaluation by the FDA; 25 of these are on the market.
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