Humira Users: Help is on the Way
Always on the cutting edge, Serve You Rx plans to offer up to three new Humira biosimilars this calendar year.
Amgen’s Amjevita upcoming launch leads the list of upcoming biosimilar versions of AbbVie’s Humira, which has long been a dynamic medical and financial success.
“We’re extremely pleased about the upcoming availability of Humira biosimilars for our clients and members,” said Serve You Rx President Ted Boylan, PharmD. “While Humira is effective at treating inflammatory conditions, it’s also very expensive.”
Serve You Rx CEO Justin Jasniewski said customers should expect a 15-20 percent savings net of rebates compared to today’s status quo with Humira.
Biosimilars are biological agents with no meaningful differences from an existing FDA-approved biologic drug, also referred to as an originator product or reference product.
Biological drugs are on the rise as illustrated by the fact that six of the top 10 global best-selling drugs of 2021 were in that category according to Fierce Pharma. They are being developed for most therapy areas and include many drug classes like insulins, monoclonal antibodies, and vaccines. Some of the most promising new drug classes – gene and cell therapies, for instance – are biologic in origin.
Approximately one in four new drugs are biologic. In 2021, the FDA approved 50 new drugs; 14 of them were biologic.
That has led to an explosion of biosimilars, four of which were FDA-approved in 2021. There are now 33 biosimilars on the U.S. market for 11 different reference products.
After the patent-protection period, it can take 5-10 years and an investment of $100-250 million to get a biosimilar to market. A drug maker must basically reverse engineer the reference product and identify an appropriate “cellular factory” to produce a biosimilar. Biosimilar manufacturers must then prove their drug has no clinically meaningful differences from the original biologic and was produced through a different manufacturing method.
Tests must confirm the biosimilar closely replicates the reference product and the drug maker must prove it can manufacture the drug safely and consistently at scale.
Amjevita will appear on Serve You Rx’s Standard and Select Formularies along with Humira.
A drug prescribed primarily to treat rheumatoid arthritis, Humira sales have averaged about $20 billion annually and the drug is one of the top-selling of all time. AbbVie has made almost $200 billion on Humira since it was introduced in 2002, and in 2021, the drug accounted for more than $29 billion in sales.
The soon release of Amjevita was a long time coming. The Humira patent expired in 2016, the same year the FDA approved Amjevita. Amjevita and other Humira biosimilars were held back from the market due mostly to patent disputes. Now that that dust has settled, six others are expected to be released in the market in the second half of 2023.
Humira is also approved for the treatment of ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The pricing of Humira has consistently increased over the last two decades. In fact, according to Managed Healthcare Executive, an individual year’s supply currently costs up to $84,000.
“We expect increased competition driven by biosimilar approvals in key categories will really help our clients and their members achieve significant savings,” Boylan said.
When it comes to evaluating newly approved biosimilars for formulary placement, Serve You Rx’s guiding principles are to “maintain quality of care, flexibility, and choice; minimize patient disruptions; improve net cost within category; and support advancement of the biosimilar market.”
Only biosimilars that are deemed clinically comparable and are manufactured by a company that can meet the demand and deliver on price will be added to the formulary list.
“We do our due diligence,” Boylan said. “And we’re pleased to share these positive results.”
About Serve You Rx
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what’s best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for over 36 years, Serve You Rx can implement new groups in 30 days or less and say “yes” to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.
Read more about Humira Biosimilars here: A New Era For Humira® Biosimilars: The Interchangeable Revolution