Biosimilars

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.

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.

A phase 3 trial sponsored by the biosimilar maker shows that its candidate, temporarily named MYL-1601D, has the same immunogenicity, efficacy and safety levels as NovoLog, Novo Nordisk’s brand-name insulin aspart. Novolog and its authorized generic currently have the U.S. insulin aspart market to themselves.

Tom Newcomer, head of U.S. market access for Samsung Bioepis, maker of Hadlima, a Humira biosimilar, said some potential customers want to see which biosimilars will grab a large market share before deciding on which one to buy

Study-based findings provide support for considerable implications of multiple switching between biosimilar and originator products.

The review focused on Remicade (infliximab) and Enbrel (etanercept). The annualized discontinuation rate was 21% among patients who had undergone nonmedical switching to biosimilars. However, the rates were similar to those found in some separate analyses of patients on reference biologics.

Several provisions in the law are designed to protect and foster the biosimilar market. But some representatives of the sector see CMS drug price negotiation as a threat to profit margins.

The Inflation Reduction Act puts a $35 cap on monthly out-of-pocket expenses for insulin. The catch: It applies only to people covered by Medicare. Some states, including California, and Civica Rx, the generic drugmaker, are gearing up to make biosimilar versions of brand-name insulin products. The competition could drive down prices.