Biosimilars

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.

Disease flareups occurred in seven women who stopped biosimilar treatment and two who continued without stopping, according to findings published in the journal Obstetric Medicine.

Humira may face competition from multiple generics next year. An octet of biologics may see competition this decade.

Metaphors of brewing beer and other concepts may help overcome some of the reluctance to prescribing biosimilars.

But the out-of-pocket costs were 47% to 59% lower for patients treated with the biosimilars Fulphia and Udenyca as primary prophylaxis for febrile neutropenia.

Price may also be persuasive. The price of the biosimilar is expected to be about 9% lower than its reference product, Lucentis.

If biosimilar acceptance is to grow, it’s going to take a great deal of work to improve the levels of trust between payers, patients, and oncologists.

The review, partly funded by Amgen, the maker of Riabni, makes the case for using the biosimilar to Rituxan for all indications of the originator.

The average sales price (ASP) for biosimilars of Neupogen has declined more than 50% since these lower cost agents began to be sold in 2015.

Pharmacy benefit managers can help health plans understand when to best leverage and align to biosimilars and other cost-effective treatments, argues Prime Therapeutics' Kelly McGrail-Pokuta.

Circle 2023 on your calendar. That's when as many as 11 biosimilars to Humira are headed for the U.S. market.

Efforts to improve education on biosimilars are a start, but payer policies must catch up to ensure real change.

Multiple patents on original biologics delay when biosimilars get on the market in the US. University of Denver Sturm College of Law legal experts argue in a preprint that changes in how the original patents are written could reduce the number of duplicative patents and legal gamesmanship.

A Cleveland Clinic researcher anticipates that the FDA’s definition of strength of formulation could impair acceptance of Boehringer Ingelheim’s biosimilar to Humira (adalimumab), even though the FDA has approved the biosimilar as “interchangeable” to Humira.

Although spending on prescription drugs marched higher in 2021, the spending might have been significantly higher were it not for the savings from biosimilars, which appear to be gaining traction, according to a new report.

Marcus Snow, MD, , chair of the American College of Rheumatology’s Committee on Rheumatologic Care, discusses how additional clinical data and interchangeability designations could help build momentum for use of Humira (adalimumab) biosimilars when they start to arrive in 2023.

In a pair of recent studies, investigators evaluated biosimilar forms of Humira (adalimumab) in prefilled syringes, prefilled pens, and autoinjector devices.

Using an aggressive utilization management approach, Providence St. Joseph Health directed physicians toward the use of biosimilars immediately after they came to market, saving nearly $27 million over two years in the process, according to Sophia Z. Humphreys, Pharm.D., M.H.A., the healthcare system’s director of system pharmacy clinical Services.

A large prospective study of the use of Rituxan (rituximab) and a biosimilar, Novex, has yielded safety data validating the use of this agent in pediatric patients with a wide range of diseases and conditions, ranging from oncologic and hematologic to neurologic.