Biosimilars

The FDA's groundbreaking decision to waive clinical efficacy studies for a monoclonal antibody biosimilar revolutionizes drug approval, reducing costs and enhancing patient access.

Bildyos and Bilprevda have the same indications as the reference products Prolia and Xgeva and are expected to be available later this year.

The biosimilar will be available to any licensed specialty pharmacy in the United States at a 95% discount from Stelara, starting January 1, 2026.

Prefilled syringes of Imuldosa now have the lowest wholesaler acquisition cost among all branded ustekinumab biosimilars, according to a news release.

Specialty drug spending rose 9.6% in 2024, but Humira biosimilar adoption is helping to slow cost increases.

Originally approved earlier this year for multiple inflammatory conditions, including rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis and COVID-19-related inflammation, Avtozma now aligns fully with the FDA-approved indications of its biosimilar, Actemra.

This biosimilars market report focuses on rising market complexity and recent activity, including two new approvals and four launches in Q2.

Since its approval in 2002, Humira has become the world’s top-selling drug—largely due to long-standing market exclusivity and rising prices in the U.S.

Wyost and Jubbonti are interchangeable with Xgeva/Prolia and are approved for all of the same indications in bone cancer and osteoporosis.

Respondents see the glucagon-like peptide 1 (GLP-1) drugs as a major advance. They also have concerns about whether insurers can afford to cover them and about wasteful prescriptions.

It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has developed are mixed.

The second part of our conversation with Craig Burton, MBA, executive director of the Biosimilars Council, a trade and lobbying group for the biosimilars industry.

We spoke recently with Craig Burton, MBA, executive director of the Biosimilars Council, a trade and lobbying group for the biosimilars industry.

Using a single PBM as the sole distribution channel is unprecedented.

Will the Stelara biosimilars be a reprise of the Humira biosimilars in 2023 and be slow to catch on?

The report also discusses the spurt of Stelera biosimilar approvals in late 2024.

In 2023, there was lower net spending and prices on adalimumab, which was likely because of rebates from AbbVie, Humira’s manufacturer, a new analysis finds.

Beginning in January 2025, Optum Rx will remove from several Humira biosimilars from its formulary, including Hyrimoz (adalimumab-adaz), the unbranded Hyrimoz and Cyltezo (adalimumab-adbm).

Celltrion’s Zymfentra is subcutaneous version of infliximab.

Amgen’s Amjevita was already on the pharmacy benefit manager’s National Preferred Flex Formulary.

7 of them launched during the first several days of July, joining Amgen's Amjevita in the suddenly crowded market of Humira competitors. Pfizer’s Abrilada is the only FDA-approved Humira biosimilar that hasn’t launched.

Boehringer Ingelheim is pricing its biosimilar 5% to 7% below AbbVie’s top selling drug.

Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.

Cuban, of "Shark Tank' fame and owner of the Dallas Mavericks, called drugs prices ‘insane’ and used some profanity when talking pharmacy benefit managers at the annual meeting of the Association for Accessible Medicines yesterday. Cuban has co-founded an online pharmacy that he says will make drug prices lower and transparent.

As a dozen Humira Biosimilars are set to enter the market this year, it seems to be unlikely that they will drive down drug costs in the future.