The Key Biosimilars Developments of 2018

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^®.

5. Mylan Confirms That It Has Launched Fulphila in the United States

Prophylaxis of chemotherapy-induced neutropenia is both crucial to successful anticancer treatment and highly expensive. The launch of Mylan and Biocon’s FDA-approved pegfilgrastim biosimilar, Fulphila, marked the first opportunity for US patients to receive a lower-cost, biosimilar version of the long-acting granulocyte colony-stimulating factor therapy. At a list price of $4175 per syringe, the biosimilar is 33% less expensive than the brand-name Neulasta.

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4. UnitedHealthcare Names 3 Biosimilars Preferred Treatments in 2019 MA Plans

When CMS announced in August 2018 that it would allow Medicare Advantage (MA) plans to use step therapy, UnitedHealthcare, the nation’s largest MA carrier, rolled out changes to its MA plans that will begin in January 2019. Now listed as preferred drugs for the payer’s MA plans are infliximab biosimilars Inflectra and Renflexis, along with the epoetin alfa biosimilar Retacrit.

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3. After Biosimilar Deals, UK Spending on Adalimumab Will Drop by 75%

In the United States, a spate of settlements between biosimilar developers and AbbVie, maker of the reference adalimumab, means that US patients are unlikely to see a biosimilar alternative to Humira before 2023. However, in Europe, where biosimilars of the product launched this October, spending on adalimumab is dropping by substantial amounts.

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2. Pfizer Calls for FDA Guidance on False or Misleading Information About Biosimilars

It is no secret that the marketplace for biosimilars is sluggish in the United States, and biosimilar developer Pfizer is taking aim at reference drug makers that it says are hindering competition by spreading misinformation about biosimilars. In August of this year, the company filed a citizen petition with the FDA in which it asked for agency guidance on appropriate sponsor communications.

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1. FDA Releases Biosimilar Action Plan

FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan. The plan outlines the agency’s ongoing efforts to improve the development and approval process, maximize regulatory clarity, develop effective communications, and support competition in the biosimilars space.

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