A biosimilar denotes a biologic product substantiated to exhibit a high degree of similarity to a previously U.S. Food and Drug Administration (FDA)-approved biologic product, referred to as the reference product. Notably, a biosimilar is characterized by an absence of clinically meaningful differences in terms of safety and effectiveness when compared to the reference product.

The FDA has biosimilar resources for health care providers. Beginning with the Overview for Health Care Professionals, you will be able to learn about biological products, including biosimilars and interchangeable biosimilars. You can find educational materials by visiting the Curriculum Materials for Health Care Degree Programs.

Approved interchangeable biosimilars may be dispensed in place of the reference product at the pharmacy without consultation with the prescriber (depending on state law). This is called a “pharmacy-level substitution.” There are only four states (WA, IN, AL, and SC) that do not permit pharmacy-level substitution of a reference product without provider authorization, but that is subject to change. Not all biosimilars are designated as interchangeable. The American Journal of Managed Care article, Understanding Interchangeable Biosimilars at the Federal and State Levels, offers an in-depth review of the pharmacy-level substitution by state and provider communication requirements.

Not all biosimilar medications are approved as interchangeable. However, health care providers may still prescribe the biosimilar. Manufacturers can seek an interchangeability designation by submitting additional switching studies to the FDA, and then the designation may be granted, subject to state law. Both biosimilars and interchangeable biosimilars must meet the same high standard of biosimilarity for FDA approval, and both are as safe and effective as the reference product. To understand more about Prescribing Interchangeable Products, visit the FDA.

Previously, the FDA recommended that labeling include a “Biosimilarity Statement” or “Interchangeability Statement” describing the product’s relationship to the reference product. However, the FDA is recommending that all labeling for biosimilars, including interchangeable biosimilars, include one statement – a “biosimilarity statement” regardless of the biosimilar being approved as interchangeable. Read the latest FDA guidance on labeling to learn more.

The Purple Book is a database containing all FDA-approved biologic products regulated by the Center for Drug Evaluation and Research (CDER), including approved biosimilar and interchangeable products, and related reference products. For a quick overview of a product, use the simple search and enter the product’s proprietary (brand) name. Returned results will list the biosimilar(s), interchangeable(s) and reference product(s). The proprietary and proper name are displayed for each, including access to the FDA-approved product label. Always check in the bottom right-hand corner when the database is last updated for the most accurate information. 

Although there are different regulatory approval pathways, biosimilars are highly similar to and have no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the FDA-approved reference product. The reference product is evaluated based on original clinical safety and efficacy studies for each indication, whereas biosimilars are evaluated based on comparative clinical studies. This abbreviated approval pathway for biosimilars was created to help reduce the time and cost of development of biologics without compromising safety and effectiveness. Visit the FDA to understand more about the review and approval process of biosimilars.

Humira has been the best-selling biologic worldwide. Upwards of 1.4 million patients have been prescribed Humira across more than 9 indications¹ which accounts for $20 billion in sales annually². In 2023, Humira lost patent exclusivity in the United States. Patients with complex diseases have more therapy options with the introduction of biosimilars for Humira. Also, due to increased competition, prescription benefit plans have the potential to save with a high-quality, clinically equivalent low-cost alternative.

Many prescription benefit plans have opted to exclude Humira from their formulary in favor of selecting biosimilars for Humira. At CVS Specialty®, we are here to minimize patient disruptions and simplify medication transitions. If your patient's therapy is no longer covered on their prescription benefit plan, you will be proactively notified about alternative options that are covered under the patient’s plan. We also help make it easy for patients to transition with specially trained CareTeam support, manufacturer injection training and connecting patients to financial assistance programs. 

¹https://www.rxabbvie.com/pdf/humira.pdf 

² https://www.humirapro.com/about-humira# 

Most biosimilars for Humira are FDA-approved for the same indications as Humira. This includes ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis. There are a few exceptions.  Refer to the CVS Specialty Humira and Biosimilars for Humira Drug List for detailed information on select FDA-approved indications by therapy. Not all FDA-approved indications are covered alternatives on your patient’s prescription benefit plan. 

No. Three pediatric indications have patent exclusivity. Biosimilars for Humira are not yet approved for hidradenitis suppurativa in patients 12–17 years; uveitis in patients aged 2 and older; and ulcerative colitis in patients 5–17 years. Refer to the CVS Specialty Humira and Biosimilars for Humira Drug List for more information on select FDA-approved indications and ages. Not all FDA-approved indications are covered alternatives on your patient’s prescription benefit plan.

Biosimilars may be more cost effective for payors and your patients. They also can provide greater access to biologic and biosimilar treatment options. When there is more than one medication available to treat a condition, pricing usually becomes more competitive. Biosimilars for Humira offer the same benefits and are designed to have the same mechanism of action that inhibits the tumor necrosis factor (TNF).

If your patient’s prescription benefit plan excludes Humira, CVS Specialty will contact you to discuss covered alternative medications. You will have several therapeutic options from which to choose based on your patient’s individual clinical profile. Biosimilars for Humira are highly similar and have no clinically meaningful differences. So, your patients can expect the same benefits and treatment effects as Humira. 

No. Based on your patient’s prescription benefit plan formulary change, CVS Specialty will contact you using your electronic health record (EHR). The message will inform you that Humira is no longer covered by your patient’s plan and provide you with covered alternative medications. If your EHR is not enabled for messaging, the pharmacy team will contact you directly by phone or fax to discuss alternative medications covered under your patient’s plan.

You can send in a new prescription before we contact you. However, all biosimilar adalimumab prescriptions received prior to the patient’s formulary change date will be held until the effective date. Patients may continue to fill Humira until the exclusion date to help minimize disruption. Once the new biosimilar for Humira prescription can be released, CVS Specialty will fill the medication according to your prescription and plan requirements. 

Yes. Once you have selected your patient’s replacement therapy, send a new prescription to CVS Specialty. Depending on your patient’s prescription benefit plan, prior authorizations (PA) for Humira might transfer to an adalimumab biosimilar. However, a new PA would need to be submitted and approved if the Humira PA is expired or you choose an alternative therapy. Please check your patient’s plan for a list of covered options.

Visit the CVS Specialty Autoimmune (AI) Drug List to access select FDA-approved AI specialty medications and infusion therapies. The list includes FDA-approved indications, available supply methods and select common adverse reactions to each therapy.

If your patient’s prescription benefit plan has a formulary change for Humira, CVS Specialty will proactively contact you to help prevent gaps in therapy. Providers will either receive a message through your electronic health record (EHR), a fax or phone call from our pharmacy team. The message will identify your patient, inform you of the formulary change and list covered alternatives based on the patient’s plan. You can complete the fax and return it to CVS Specialty, or you can send us a new prescription electronically. All prescriptions received will be held until the effective date of the formulary plan change. 

No. If your patient already has a prior authorization (PA) for Humira, most prescription benefit plans will transition the PA to the preferred adalimumab biosimilar. If your patient’s PA has expired, a renewal should be requested.

CVS Specialty has developed Prescribing Guide: Biosimilars for Humira, which includes information about biosimilars for Humira, the brand name vs. chemical name, when a branded and unbranded product is dispensed, and how best to send prescription referrals. Refer to the CVS Specialty Humira and Biosimilars for Humira Drug List to view FDA-approved indications as well as dosages and device types available.

Biosimilars for Humira may have more than one manufacturer. CVS Specialty is manufacturer agnostic and will dispense based on the patient’s prescription benefit plan and available supply. 

Some adalimumab manufacturers have chosen to market both branded and unbranded versions of their products. Since branded and unbranded biosimilars from the same manufacturer share the same biologics license application (BLA), they are considered interchangeable with one another. Refer to the CVS Specialty Humira and Biosimilars for Humira Drug List to access select FDA-approved branded and unbranded options.

CVS Specialty has created a Patient Biosimilars Resource Center with educational videos, frequently asked questions, and links to FDA resources. We have a specially trained autoimmune CareTeam dedicated to supporting patients transitioning to a biosimilar for Humira. Pharmacists and clinicians are available to answer patients’ questions, educate them on alternative medications and make the transition as seamless as possible. To learn more about biosimilars, patients can visit Biosimilar Basics for Patients on the FDA website.

We have a specially trained autoimmune CareTeam dedicated to supporting patients transitioning to a biosimilar for Humira and will proactively help patients connect to financial assistance programs. Specialty pharmacists are ready to answer questions about symptoms, side effects, dosages and any other medication needs through secure messaging and live chat. CVS Specialty can also connect your patients to manufacturer injection training, so they can be confident in self-administering therapy. CVS Specialty continuously trains our CareTeams to help manage patients’ concerns throughout their transition to a biosimilar for Humira.

Depending on your patient’s prescription benefit plan, your patient may receive a letter 30-60 days prior to the formulary change effective date notifying them that Humira is no longer covered and provide information about available covered alternatives.

If your patient has previously filled a prescription for Humira (adalimumab) and their plan is changing, they will receive an email or a text message from CVS Specialty. The message will include educational resources on biosimilars and a notification that their medication has changed. Patients must provide consent to receive digital messages. They can register online or use our mobile app once they have received their first medication shipment. If they have not received their first medication shipment, they can pre-register at CVSspecialty.com/digital

Yes. Just like Humira, these biosimilars have their own manufacturer patient support and/or copay assistance programs. Additionally, CVS Specialty can help connect patients to financial assistance programs. Patients approved for assistance typically qualify for one year. Some financial support is monetarily capped and requires patients to reapply annually. Funding criteria varies by manufacturer, organization, foundation and/or program. Payor requirements may affect eligibility and level of assistance.

For transitions to a biosimilar for Humira, CVS Specialty will proactively reach out to patients when financial assistance may be needed and/or available. 

If your patient cannot use a covered alternative medication for a medical reason, you can request a medical necessity review as early as April 1. Your patient’s pharmacy benefit plan will review it and determine if your patient qualifies for a medical exception.