Streamlining biosimilar prescribing and transitions

A biosimilar denotes a biologic product substantiated to exhibit a high degree of similarity to a previously FDA-approved biologic, 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.

To find out if a medication has an approved biosimilar, access the FDA’s Purple Book. It is a searchable database of all FDA-approved, “licensed” biologic products, including the licensed biosimilar, interchangeable product and their reference products.

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.” 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. Requirements vary by state and are subject to change.

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. Access the FDA’s Purple Book to find out if the biosimilar has an FDA-approved interchangeable product. To understand more about Prescribing Interchangeable Products (PDF), 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 now recommending that all labeling for biosimilars, including interchangeable biosimilars, include one statement – a “biosimilarity statement” regardless of the biosimilar being approved as interchangeable. 

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 (adalimumab) has been the best-selling biologic worldwide. Upwards of 1.4 million patients have been prescribed Humira across more than nine indications¹ which accounts for $20 billion in sales annually². The adalimumab molecule  offers the same benefits and is designed to have the same mechanism of action that inhibits tumor necrosis factor (TNF) protein.

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 on cost 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.ajmc.com/view/humira-the-first-20-billion-drug

²https://www.rxabbvie.com/pdf/humira.pdf (PDF)

Stelara (ustekinumab) gained 20 percent market share in the U.S. Crohn’s disease drug market in 2022, generating $1.5 billion in sales of $7.4 billion. It is second only to Humira. In 2024, Stelara’s global sales were $10.36 billion.¹ Stelara is FDA-approved for four indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The ustekinumab molecule is a monoclonal antibody, which offers the same benefits and is designed to have the same mechanism of action that inhibits inflammatory cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23).

Some prescription benefit plans have opted to exclude Stelara from their formulary or biosimilars for Stelara as an additional covered medication. 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 covered alternatives. 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://gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership

²https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf (PDF)

Most biosimilars for Humira are FDA-approved for the same indications the reference product, 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. Biosimilars for Humira use the adalimumab molecule that offers the same benefits and is designed to have the same mechanism of action that inhibits tumor necrosis factor (TNF) protein.

Refer to the CVS Specialty® Humira and Biosimilars for Humira Drug List (PDF) 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. 

Most biosimilars for Stelara are FDA-approved for the same indications as the reference product, Stelara. This includes plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Biosimilars for Stelara use the ustekinumab molecule, a monoclonal antibody, which offers the same benefits and is designed to have the same mechanism of action that inhibits inflammatory cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23).

Refer to the CVS Specialty® Stelara and Biosimilars for Stelara Drug List (PDF) 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. One pediatric indication has patent exclusivity. Biosimilars for Humira are not approved for ulcerative colitis in pediatric ages 5–17. Not all biosimilars for Humira are approved for every indication or age group. Refer to the CVS Specialty® Humira and Biosimilars for Humira Drug List (PDF) for select FDA‑approved indications and ages. Coverage of FDA‑approved biosimilars may vary by prescription benefit plan.

It depends. Biosimilars for Stelara are approved for pediatric ages 6+ for psoriatic arthritis and plaque psoriasis. For Crohn’s disease, only the Stelara reference product is approved for pediatric ages 2+. Refer to the CVS Specialty® Stelara and Biosimilars for Stelara Drug List (PDF) for select FDA‑approved indications and ages. Coverage of FDA‑approved biosimilars may vary by 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.

If your patient’s prescription benefit plan excludes Humira or Stelara, 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 are highly similar and have no clinically meaningful differences. So, your patients can expect the same benefits and treatment effects as Humira or Stelara. 

No. Based on your patient’s prescription benefit plan formulary change, CVS Specialty^® will contact you using your 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.

You can send in a new prescription before we contact you. However, all biosimilars for Humira prescriptions received prior to the patient’s formulary change 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 patient’s prescription benefits plan. 

It depends on the patient’s prescription benefit plan. In many cases, a new prescription is required when transitioning a patient from Stelara to a biosimilar. Review your patient’s plan for covered alternatives. If a new prescription is required, send the biosimilar prescription to CVS Specialty.

Biosimilars for Stelara prescriptions received before the formulary effective date will be held until the change takes effect. Patients may continue to receive Stelara until the exclusion date to help minimize disruption. Once the biosimilar prescription can be released, CVS Specialty will dispense the medication according to the patient’s prescription benefit plan.

Yes. Once you have selected your patient’s replacement therapy, send a new prescription to CVS Specialty®. A new prior authorization would need to be submitted and approved for the replacement therapy. Check your patient’s plan for a list of covered medications.

Visit the CVS Specialty® Autoimmune (AI) Drug List (PDF) 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, CVS Specialty® will proactively contact you to help prevent gaps in therapy. You will either receive a message through your 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 request 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. If your patient needs to refill before the formulary change, we will continue to fill the original prescription.

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.

In many cases, yes. A PA may be required when transitioning a patient from Stelara to a biosimilar. Review your patient’s prescription benefit plan to confirm covered ustekinumab alternatives and PA requirements. If a new PA is needed, submit a request for biosimilar therapy.

CVS Specialty® has developed biosimilar prescribing guides for both Humira (PDF) and Stelara (PDF), which includes information about the biosimilars, 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 biosimilar drug lists for Humira (PDF) and Stelara (PDF) to view FDA-approved indications, as well as dosages and device types available.

Biosimilars for Humira and Stelara 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 and ustekinumab 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® biosimilar drug lists for Humira (PDF) and Stelara (PDF) 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 biosimilars or alternative medications and can help patients connect to third-party financial assistance programs. Specialty pharmacists are ready to answer questions about symptoms, side effects, dosages and any other medication needs through secure 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 biosimilars or alternative medications.

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 or Stelara are no longer covered and provide information about available covered alternatives.

Yes. When a new prescription is received by CVS Specialty®, the patient will receive an email or text message. If the patient has signed up for digital communications, they will get a notification. Patients may also receive messages with links to biosimilar resources and how to contact us for support.*

It depends. Some biosimilars have their own manufacturer patient support and/or copay assistance programs. CVS Specialty® can help connect patients to third-party 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.

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