Tony Hagen

Samsung Bioepis executive Tom Newcomer’s touts the 10-year-old biosimilar company’s achievements as it gets ready to launch its Humira biosimilar, Hadlima.

Hadlima is scheduled to be on to the market in July 2023. In an interview with Managed Healthcare Executive®, a Samsung Bioepis executive says data on Hadlima’s interchangeability won’t be ready till 2024.

Tom Newcomer, head of U.S. market access for the maker of Humira biosimilar Hadlima, deflected questions on price but touted the drug’s track record overseas.

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

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.

Some companies are using the interchangeability designation as a marketing ploy.

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.

Amgen’s biologic won’t have biosimilar competition till 2029. But the possibility that up to 11 Humira biosimilars may come on the market in 2023 could exert some downward pressure on Enbrel’s price.

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.

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

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.

Off-label Avastin, Eylea and Lucentis are the primary treatments for neovascular age-related macular degeneration (AMD), a leading cause of blindness. A recent review article looked at the impediments to the biosimilars for these drugs Ophthalmologists are wary about using biosimilars to Avastin (which was approved as a cancer drug) for AMD. Biosimilars to Eylea and Lucentis are not on the market yet. Manufacturers’ rebates and Medicare Part B “buy and bill” policies could make it difficult for them to compete against their brand-name “originator” products.

The company announced this week that it is selling its biologics unit to Biocon Biologics, but Viatris is also slated to have a stake in the biosimilars entity that will bring together Biocon Biologic’s biosimilar operations and those that Viatris is selling off.