Biosimilars

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

In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the biosimilar market.

Switching to Humira biosimilars saved Navitus clients more than $315 million in upfront costs in 2024 and resulted in a 60% reduction in net costs per claim.

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 FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.

There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.

Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.

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.

The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis.

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.

Biosimilars started to gain a firm foothold in the market this year and could take off in 2023 with the advent of Humira biosimilars. Our articles about biosimilars were some of the most viewed of the year.

Kareem Karara, Pharm.D., BCPS, CCHP, spoke about unbranded biologics, which are identical the branded products. They are coming on the market amid a growing number of biosimilars.

OptumRx will offer Amjevita and two other biosimilars alongside Humira. OptumRx is the first large PBM to make public its plans for the seven Humira biosimilars that may come on the market next year.

The question of whether it is safe to switch among biosimilars, not just between biosimilars and the reference product, is coming more pertinent as the number of biosimilars on the market increases.