Questions about Humira biosimilars?

After years of patent protection, biosimilars for Humira are set to enter the US market in 2023. The arrival of these drugs has been widely anticipated throughout the healthcare industry. Yet, their place and cost remain fairly misunderstood.

For over a decade, Humira has been the highest-grossing drug in the world, bringing in some $21 billion for manufacturer AbbVie in 2021. Humira is a versatile drug used to treat multiple autoimmune diseases, such as rheumatoid arthritis, Crohn’s disease, psoriasis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.

The availability of Humira biosimilars potentially affects a vast number of patients and healthcare professionals. Our team of clinicians explored all of the different biosimilars set to enter the market this year in a recent white paper. Below are answers to some of the most frequently asked questions about Humira biosimilars.

How are biosimilars different from generics?

Humira is a biologic drug made from living organisms. It can’t be exactly replicated the way a chemical compound can. Biosimilars are just that - similar. They have the same effect as the “reference product,” but are not an exact copy.

I find wine to be a helpful comparison. To be called champagne, a wine has to be a sparkling combination of chardonnay, pinot noir, and pinot meunier from northern France. While they share certain characteristics, each producer’s champagne is a little different.

Are biosimilars new? Why are Humira biosimilars hitting the market now?

The Biologics Price Competition and Innovation Act (BPCI Act) in 2010 provided an abbreviated approval pathway for biosimilars. Other types of biosimilars, such as oncology drugs, have since gained widespread usage. Humira biosimilars have had FDA approval since AbbVie’s patent expired in 2016, but litigation prevented them from reaching the market until 2023.

What is the difference between high-concentration and low-concentration Humira biosimilars?

Humira launched in 2002 with a formulation of 50 mg/ml. In 2018, after the FDA approval of additional indications, AbbVie released a citrate-free high-concentration (100mg/ml) formulation of the drug, designed to decrease injection volume for higher doses and also reduce pain at the injection site. The high-concentration version currently accounts for about 85% of the market share.

Out of the 14 Humira biosimilars projected to reach the US market in 2023, only six are high concentration. Amgen’s Amjevita, the first Humira biosimilar to launch, is a low-concentration formulation. So far, the only high-concentration Humira biosimilar with FDA approval is Samsung Bioepis and Organon's Hadlima HC, which is expected to launch in the summer. Additionally, all of the FDA-approved Humira biosimilars will offer citrate-free formulations, with the exception of Sandoz’s Hyrimoz.  

What is biosimilar interchangeability? Are there interchangeable biosimilars for Humira?

While certain generics can be substituted by the pharmacist without contacting the prescriber, biosimilars require their own prescription, unless they are designated interchangeable. Biosimilars are already more difficult to get approved than generics, and the interchangeable designation is harder still to obtain.

Currently, Boehringer Ingelheim’s Cyltezo (a low-concentration product) is the only Humira biosimilar with interchangeability. Other manufacturers are in the process of seeking this designation for their products.

How widely adopted are Humira biosimilars likely to be?

When a medication is working, providers and patients are reluctant to switch. With an annual cost of about $80,000 per year for Humira, there may seem to be significant motivation for them to give biosimilars a try. However, the biosimilar must offer significant cost savings to all stakeholders, along with comparable patient support services, in order to get patients to switch.

Formulary status and interchangeability will be key. Approximately two-thirds of gastroenterologists, dermatologists, and rheumatologists said they would be unlikely to prescribe a Humira biosimilar without the interchangeable designation. (Of course, if the drug is interchangeable, they wouldn’t have to prescribe it, but that’s beside the point.)

The agreements biosimilar manufacturers struck with AbbVie to allow the release of Humira biosimilars in 2023 stipulate that biosimilars can’t offer a lower-out-of-pocket cost to the patient. There are workarounds, such as co-pay cards and manufacturer assistance, but AbbVie offers these as well.

As a result, Humira biosimilars are not likely to produce dramatic cost reductions in the short term. After reviewing all of the currently available information about formulary placement, it seems likely that biosimilars may capture up to 5% of the market in the first year, and potentially 20-25% in the next three years.
 

About the author

Image

Ralph Pisano, RPh, is president of Nuwae, a company focused on reinventing patient drug access and affordability. Nuwae is part of the Goodroot community of companies and its commitment to lowering healthcare costs. He has more than 30 years of pharmacy experience.