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Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI (ustekinumab-aekn) with STELARA (ustekinumab)

On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab)....more

Accord BioPharma, Inc. Announces FDA Approval of HERCESSI (trastuzumab-strf)

On April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf).  HERCESSI is a biosimilar to HERCEPTIN (trastuzumab) and is indicated for adjuvant...more

FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

​​​​​​​Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental...more

Year in Review: Top-Five U.S. Biosimilar Market Developments of 2021

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2021. Here are our top five...more

Express Scripts Adds Biosimilar SEMGLEE to Preferred Formulary

In October, Express Scripts announced that it would add Viatris’ SEMGLEE (insulin glargine-yfgn) injection as a preferred therapy on its formulary beginning in January 2022. Back in July, the FDA approved SEMGLEE as the first...more

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