In early 2023, competitors for AbbVie’s biologic drug Humira (D2E7, adalimumab) began entering the U.S. market. As of fall 2023, eight biosimilars were available for Humira. Each one represents competition for a biologic that, in its time, represented a major treatment breakthrough and a significant source of revenue for AbbVie.
Humira is currently indicated for 10 conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, writes Adam Zamecnik in Pharmaceutical Technology. As biosimilars enter the market, providers and payers are taking note — and calling for changes in the way that specialty pharmacies manage patients on the treatment.
Humira’s competition represents only the beginning of specialty pharmacy trends wherein biosimilars enter the market to compete directly against biologics. Specialty pharmacies that learn from these changes with Humira will be better positioned to manage future biosimilar go-to-market strategy entries.
Humira Competitors Currently on the Market
Amgen led the way in January 2023 when it launched its adalimumab biosimilar Amjevita (adalimumab-atto). For six months, Amjevita was the only competitor to Humira on the market.
The situation changed in July 2023, writes Peter Wehrwein, managing editor at Managed Healthcare Exclusive. That’s when seven additional biosimilars entered the market to compete with Humira and Amjevita:
- Boehringer Ingelheim’s Cyltezo (adalimumab-adbm).
- Organon and Samsung Bioepis’ Hadlima (adalimumab-bwwd).
- Biocon Biologics’ Hulio (adalimumab-fkjp).
- Sandoz’s Hyrimoz (adaluimumab-adaz).
- Freseniuys Kabi’s Idacio (adalumumab-aacf).
- Celltrion Healthcare’s Yuflyma (adalimumab-aaty).
- Coherus Biosimilar’s Yusimry (adalimumab-aqvh).
The only expected Humira biosimilar not to launch in July 2023 was Pfizer’s Abrilada (adalimumab-afzb). Pfizer announced its decision to hold off on the launch to seek an interchangeability designation from the U.S. Food and Drug Administration (FDA). Currently, only Cyltezo has interchangeability status from the FDA.
Adalimumab is not the only biologic facing competition now or in the future. As companies work to create biosimilars for other biologic treatments, pharmacies can expect to see more questions arise about the use of biosimilars, their costs and their interchangeability status. That means specialty pharmacies need to be equipped with the information (and products) of the biosimilars.
More Competing Biosimilars Are on the Horizon
Humira’s biosimilar competitors aren’t the first biosimilars to join a biologic on the market. The first FDA approval for a biosimilar appeared in 2015, when the agency approved Sandoz’s Zarxio (filgrastim-sndz) for treatment of neutropenia and all other conditions included in Neupogen (filgrastim)’s labeling.
More biosimilars are in the pipeline to compete with Neupogen and with other biologics currently on the market, writes Sophia Z. Humphreys of Sutter Health. These include:
- Six biosimilars under development for Avastin (bevacizumab).
- Five under development for Herceptin (trastuzumab).
- Four biosimilars under development for Rituxan (rituximab).
- Competitors with Stelara (ustekinumab), which loses exclusivity in 2023.
- Competitors with Simponi (golimumab) and Cimzia (certolizumab pegol), which both lose their exclusivity in 2024 and are expected to see competitors appear the same year.
- Expansion of biosimilars into care classes like ophthalmology, bone health and the treatment of autoimmune disorders.
Biologics with no current biosimilar competition and those with competitors already on the market will both face changes as new biosimilars appear. Specialty pharmacies will also have to juggle patients’ needs, providers’ preferences, payers’ contract rules and distributors’ capabilities in ensuring that the right treatments get to the right patients in a timely manner.
Specialty Pharma Trends Created From Biosimilar Adoption
The entry of biosimilars competing with Humira has already created a number of new challenges for providers, patients, payers and pharmacies. Understanding these pharma market insights can help specialty pharmacies address them now and prepare for future waves of biosimilar competitors in the future.
Biologics Will Still Have Their Place
First, the entry of biosimilars isn’t likely to spell the end for Humira. Sales of Humira peaked at $18.9 billion in 2022, but the drug is still expected to generate $15.2 billion through the end of 2024, writes Sally Turner in Pharmaceutical Technology. Humira’s status as “the world’s best-selling drug” is unlikely to be decimated by the entry of biosimilars.
At least part of Humira’s continued success will rely on the way in which biologics and biosimilars work. While standard medications’ active ingredients can be copied exactly, biologics’ active ingredients can only be approximated — hence the term “biosimilars” rather than “generics.” For some patients, Humira will remain the best available option.
Planning Ahead for PBM Negotiations Can Smooth Operations
Amgen’s Amjevita, the company’s biosimilar competitor to Humira, faced obstacles after its January 2023 launch in the United States. Several of these go-to-market strategy obstacles involved how pharmacy benefits managers (PBMs) treat the biosimilar in their formularies.
For instance, Amgen launched Amjevita at two price points — one 55 percent below Humira’s list price and the other at 5 percent below. Amgen expected the 55 percent price point to be more popular, but rebate dynamics resulted in the higher price point becoming more popular with PBMs, says Murdo Gordon, chief of global commercial operations at Amgen.
Another hurdle for Amjevita — and for other biosimilars — lies in the timing of PBM contract negotiations. “Many of the PBMs are on record saying they haven’t done a whole lot in terms of driving utilization of biosimilars but plan to do more of that in 2024,” says Gordon.
Different States, Different Rules, Different Pharma Market Insights
Cyltezo’s status as an “interchangeable” option for Humira allows the former to be swapped in for the latter, in the same way a generic drug can be swapped in for a name brand one. However, U.S. states currently differ on exactly how this process works, says Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim.
For example, some states require a specialty pharmacy to call a provider’s office and get direct verbal authorization to switch a biologic with an interchangeable biosimilar. Other states allow this communication to be made electronically, such as via email or fax.
Pagnotta says that Boehringer Ingelheim is addressing this issue by offering providers state-specific training in how to substitute Cyltezo for Humira. Pharmaceutical reps work directly with providers to understand the process. For specialty pharmacies, similar information will be essential.
To Manage Biosimilars Effectively, Specialty Pharmacies Need Data
PBMs’ response to Amjevita and other biosimilars provide a clear example of the unpredictability of human decisions and market dynamics. And this unpredictability comes from one source — pharmacy benefits managers. Multiply this unpredictability by every participant in the chain between patient and treatment, and the factors become too numerous for one specialty pharmacy to handle without assistance.
A single digital point of communication like Hub software enabled with competitive insights can provide that assistance. Through the Hub, specialty pharmacies can collect and analyze the data they need to understand and address patient, provider, payer, and distributor decision making. They can manage their own inventories and efforts more effectively, getting necessary biosimilars into the hands of patients who need them.
Humira was a “first” in many ways, including in how a biologic drug deals with multiple biosimilar competitors. For specialty pharmacies, learning from these “firsts” can help smooth the path as additional biosimilars enter the market in coming years. Having access to a single source of information and communication, like a digital Hub platform, will help specialty pharmacies manage information, answer questions and transition smoothly from a world where one treatment exists to one in which competing biosimilars offer options for a number of conditions.
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