In May, the FDA approved three interchangeable biosimilars that were the first for their reference drugs. With an additional three approvals in June, that brings the total number of biosimilars to 57 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With the three agents approved in May also gaining interchangeability status, that brings the count of interchangeable biosimilars to 15. While the market is certainly heating up, it still is grappling with issues such as expected rebates, maintains one industry expert.

On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy). On June 28, the FDA approved a third Eylea biosimilar, Formycon AG and Klinge Biopharma GmbH’s Ahzantive (aflibercept-mrbb) for the same indications as the first two agents, but it does not have interchangeable status.

When the biosimilar pathway was first established, it created a two-tier system of biosimilars and interchangeable biosimilars, but multiple attempts have been made recently to level the playing field. In the latest move, the FDA proposed doing away with switching studies for interchangeables. But while the move could bring biosimilars onto the U.S. market faster and result in more competition, industry efforts are divided about whether it could prompt broader payer uptake.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

Although CVS Health Corp.’s move to drop Humira from its main template formularies did help adalimumab biosimilars finally chip away at the blockbuster drug’s dominant market share, that effect appears to be leveling off, according to industry analysts.

CVS said earlier this year that starting in the second quarter of 2024, it will remove AbbVie’s autoimmune condition treatment Humira from major national commercial formularies, instead preferring biosimilars including Sandoz’s Hyrimoz. Notably, CVS subsidiary Cordavis, which the firm launched in 2023, has a contract with Sandoz to commercialize a co-branded, low-list-price version of Hyrimoz. Cordavis also has a deal with AbbVie to produce a limited amount of co-branded version of Humira.

BCS Financial Corp. unveiled the Gene Therapy Rider on its EssentialCare Critical Illness insurance policy, the company said on June 18. The offering by the insurance and financial services company, which is owned by all 34 Blues plans, can pay the entire policy face value amount when a beneficiary is diagnosed with a covered disease and chooses to undergo treatment with an FDA-approved gene therapy. “The payments, which are based on the policy's face value, are made directly to the insured to use how they see fit,” says the company.

Prime Therapeutics LLC and Magellan Rx Management launched the technology-enabled specialty pharmacy solution Pharmacy Match, the companies said June 19. The offering, which is powered by Free Market Health’s cloud-based technology platform, is designed to drive competition by comparing prices across the market for specialty drugs and identifying the specialty pharmacy “best suited to meet their needs.” It also tracks each claim through fulfillment.

The FDA recently took another step toward levelling the playing field between biosimilars and interchangeable biosimilars when it proposed doing away with switching studies for interchangeable products. While the draft guidance may receive some resistance, ultimately it should help provide clarity that all biosimilars are similar in their safety and efficacy, bringing these agents onto the U.S. market faster and prompting more competition among the agents, industry experts maintain.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

A recent survey from the Pharmaceutical Strategies Group (PSG) found that 33% of health plans and employers provide coverage for GLP-1 medications for obesity and 91% cover them for Type 2 diabetes. While an additional 19% of respondents said they were considering covering the drugs for obesity, plans and companies that do not cover the medications indicated they were primarily concerned with their high costs or considered them as lifestyle drugs rather than as pharmaceuticals to treat obesity as a disease.

“In an ideal world, if these drugs were really cheap, everyone would cover them for obesity,” says Morgan Lee, Ph.D., PSG’s senior director of research and strategy and one of the report’s authors. However, she notes GLP-1 medications such as Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly & Co.’s Zepbound (tirzepatide) have a wholesale acquisition cost of about $13,000 per year, and more than 40% of the U.S. population is obese. If 40% of a payer’s members take GLP-1s, Lee says the financial impact could be “terrifying.”

The House Ways and Means Committee on June 27 cleared legislation authorizing Medicare Part D plans to cover obesity drugs for new enrollees who had commercial coverage for the treatments in the year prior to aging into the program, a move that may prove to be largely symbolic because of its limited impact.

The bill is a significantly slimmed down version of the Treat and Reduce Obesity Act (TROA) and was offered at the markup by committee leadership as a substitute for the original bill. TROA advanced in a bipartisan 36-4 vote.

Currently, obesity drugs are not defined as “covered” Part D drugs. The bill would allow, but not require, plans to cover the treatments for obesity in some individuals.

A recent survey from the Pharmaceutical Strategies Group (PSG) found that 33% of health plans and employers provide coverage for GLP-1 medications for obesity and 91% cover them for Type 2 diabetes. While an additional 19% of respondents said they were considering covering the drugs for obesity, plans and companies that do not cover the medications indicated they were primarily concerned with their high costs or considered them as lifestyle drugs rather than as pharmaceuticals to treat obesity as a disease.

“In an ideal world, if these drugs were really cheap, everyone would cover them for obesity,” says Morgan Lee, Ph.D., PSG’s senior director of research and strategy and one of the report’s authors. However, she notes GLP-1 medications such as Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly & Co.’s Zepbound (tirzepatide) have a wholesale acquisition cost of about $13,000 per year, and more than 40% of the U.S. population is obese. If 40% of a payer’s members take GLP-1s, Lee says the financial impact could be “terrifying.”

Medicare Part D plans are likely to revise their biosimilar formulary management policies as a result of recent regulatory changes, not least the Inflation Reduction Act (IRA). Part D payers will also be on the hook for a greater share of the cost of biosimilars going forward.

A study in Health Affairs released in May makes the case that the longstanding gap in the coverage of biosimilar products between employer-sponsored insurance plans and Medicare Part D plans is likely to shrink in 2025, when several key components of the IRA take effect.

Notable pharmacy benefit trends in 2023 claims data included increased use of GLP-1s for weight loss, shifting market dynamics amid high demand for AbbVie Inc.'s Humira (adalimumab) and its biosimilar competitors and increasing approval of expensive gene therapies. All this took place amid “persistent price inflation” across most drug categories, according to a new report by PBM analytics firm Xevant.

According to Xevant’s 2023 Drug Trend Report, which analyzed pharmacy claims data from its commercial plan clients, 2023 plan-paid amounts across all brand and generic non-specialty and specialty drugs went up an average of 20% from 2022. In addition, the number of specialty prescriptions processed by plans increased by 11% in 2023. GLP-1 utilization increased by 400%, while claims for Humira and its biosimilars increased by 25%.