Biosimilars

Since CVS Health Corp. dropped the blockbuster drug Humira (adalimumab) from its national commercial template formularies on April 1, the number of prescriptions written for Humira biosimilars has jumped from just 5% to 36%, according to a recent equity analyst report.

Speakers at the Academy of Managed Care Pharmacy (AMCP) conference in New Orleans said the development is encouraging and could change the game for future biosimilars — including those in the pipeline for another immunosuppressive drug, Stelara (ustekinumab). But clinicians speaking at the conference also said that the transition to biosimilars has not always gone smoothly for patients.

For example, rheumatologist Mark Box, M.D., said the potential cost savings associated with switching patients to biosimilars compared to the administrative burden on providers “often does not balance.”

When then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, he established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved almost 50 biosimilars, with about one-fifth of those gaining interchangeable status. That distinction, however, has been increasingly under fire, most recently in President Biden’s fiscal year (FY) 2025 budget, which proposes eliminating the interchangeability designation entirely. That could help boost uptake of biosimilars, resulting in prescription drug savings, say some industry experts.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

Amylyx Pharmaceuticals, Inc. said on April 4 that it was voluntarily discontinuing the marketing authorization for Relyvrio (sodium phenylbutyrate and taurursodiol) in the U.S. and in Canada, where it is known as Albrioza. As part of a restructuring, the company also is laying off about 70% of its workforce. The FDA approved the agent for the treatment of amyotrophic lateral sclerosis (ALS) on Sept. 29, 2022, based on data from a Phase II trial involving 137 people. But on March 8, the company revealed that its Phase III PHOENIX trial did not meet the prespecified primary or secondary endpoints. Prior to the drug’s approval, the FDA’s Peripheral and Central Nervous System Drugs Advisory committee found that the study did not provide substantial evidence that the therapy was effective, but during a second meeting in September reversed course in favor of approval. At the time of Relyvrio’s approval, Amylyx co-founder and co-CEO Justin Klee declared that “if the PHOENIX trial is not successful, we will do what's right for patients, which includes taking the drug voluntarily off the market.” The company will not allow any new prescriptions for the drug, but it will transition current patients who wish to remain on treatment with Relyvrio to a free drug program. Amylyx will present topline data from the PHOENIX trial at the American Academy of Neurology Annual Meeting in Denver on April 16.

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

The FDA approved the first biosimilar in 2015, and since then, almost 50 more have been greenlighted. Last year saw the biggest influx of these competitors onto the U.S. market, and a recent Cardinal Health report, titled 2024 Biosimilars Report: Insights on a pivotal year of evolution and expansion, highlights this burgeoning market.

Since 2015, biosimilars have saved $23.6 billion, with $9.4 billion of that total coming in 2023 alone. Last year saw the long-awaited competition to the top-selling Humira (adalimumab) from AbbVie Inc., with nine biosimilars launching, two of them with interchangeable status, an important differentiator to providers. “As the top-selling drug in the world with annual sales of $20 billion in 2022, the potential monetary impact of increased market competition cannot be overstated,” says the report.

PBMs often place biosimilar medications on preferred formulary tiers soon after the drugs hit the market, a change from a few years ago, when payers were more hesitant to cover biosimilars, according to a recent Cardinal Health report. However, one of the report’s authors tells AIS Health that PBMs in some cases have kept the reference biologic product on their preferred tier as well, leading to slower adoption of biosimilars.

For instance, Fran Gregory, Pharm.D., Cardinal Health’s vice president of emerging therapies, notes that CVS Health Corp.'s Caremark, The Cigna Group's Express Scripts and UnitedHealth Group's Optum Rx all added Humira (adalimumab) biosimilars to their national preferred formularies when they launched last year. Gregory says those PBMs were “very strategic” about which of the nine Humira biosimilars to place in a preferred tier, analyzing the wholesale acquisition costs (WACs) and concentrations of the products and tailoring them “based on the lines of business they’re serving.” But the payers all put the same tier as the biosimilars, which Gregory says “is where the challenge lies” with adoption.

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

Coherus BioSciences, Inc. launched its Udenyca Onbody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), the company said Feb. 21. Approved Dec. 22, the OBI is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca was first approved Nov. 2, 2018, and the leukocyte growth factor is one of six biosimilars of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency has greenlighted. A health care provider must fill the OBI with the co-packaged syringe and apply it to the patient’s abdomen or back of the arm. About 27 hours after it is applied to the skin, the OBI will deliver a 6 mg/0.6 mL dose of Udenyca over about five minutes.

Catalyst Pharmaceuticals, Inc.’s Agamree (vamorolone) is now available in the U.S., the company said March 13. The FDA approved the first-in-class corticosteroid on Oct. 26 for the treatment of Duchenne muscular dystrophy in people at least 2 years old. The company is offering the comprehensive support program Catalyst Pathways Patient Assistance Program for Agamree for eligible patients. Drugs.com lists the price of 40 mg/mL oral suspension as more than $10,013.

Global spending on medications is expected to hit $2.3 trillion by 2028, as not only more therapies become available but also more people have access to them. That’s one of the findings of the IQVIA Institute for Human Data Science’s recent report titled The Global Use of Medicines 2024: Outlook to 2028. Oncology and obesity, among other therapeutic classes, are expected to be among the top areas in global spending over the next five years, estimated researchers.

The FDA approved the highest number of novel therapies in years in 2023, and multiple potential blockbusters are slated for decisions in 2024. In addition, the Inflation Reduction Act looms large over the pharma industry as HHS negotiates the prices of the initial 10 Medicare Part D agents and lawsuits over the legality of the IRA play out. And while life sciences dealmaking was down a bit in 2023, the new year already looks to be more promising. AIS Health, a division of MMIT, spoke with some industry experts about their outlook for 2024.

AIS Health: What are some pharma issues to keep an eye on in 2024, and why?