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The year 2018 was a banner year for biosimilars, with the number of FDA-approved biosimilar products nearly doubling, and with major policy, business, and regulatory developments that moved the biosimilars marketplace forward. Here are 5 of the top developments in biosimilars for the past year, as reported by The Center for Biosimilars®, a sister site of The American Journal of Managed Care®.

The House has passed a bill that would support state efforts to investigate pregnancy-related deaths and research how to prevent future deaths; a column in The New York Times examined 4 specific drug pricing policies and had 3 health policy experts weigh in on what the outcomes of implementing these policies could be; despite the benefits of using biosimilar filgrastim, the United States has lagged behind other countries in adopting the therapy.

This week, the top managed care news included the Trump administration giving governors the power to overhaul section 1332 waivers under the Affordable Care Act (ACA); CMS disclosed a breach in the portal that agents and brokers use to assist consumers signing up for health coverage under the ACA; about one-third of all US healthcare payments in 2017 were tied to alternative payment models.

Since biosimilars gained a US approval pathway as part of the Affordable Care Act, these follow-on drugs have been widely seen as a key way to address the problem of high-cost biologic drugs. However, cost savings have been disappointing as only 12 biosimilar products have been approved to date, and just 4 have become commercially available. That’s a reality that led FDA Commissioner Scott Gottlieb, MD, to call the US market for biosimilars “anemic.”

On June 14, 2018, the Senate Judiciary Committee voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Here are 5 key things to know about the proposed legislation.

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