Biologics are medications made from living sources and are complicated to produce. Some examples of biologics are insulin, hormones and vaccines. Biosimilars are medications that are highly similar to the reference product (original biologic) and are already approved by the U.S. Food and Drug Administration (FDA). Biosimilars have no clinically meaningful differences compared to the reference product, and they are as safe and effective. Biosimilars provide the same treatment benefits and have the same risks. Both biologics and biosimilars are approved by the FDA to treat conditions like Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, diabetes and more. Visit Biosimilar Basics for Patients to learn more.

Yes. Biosimilars and generics are both version of medications already approved by the FDA. Biosimilars are made from living sources and are complicated to produce. They are highly similar and have no clinically meaningful differences than the reference product (original biologic). Generics are copies of brand-name drugs and generally made from chemicals. Like generics, biosimilars may cost less because manufacturers rely on the FDA’s finding that the reference products are safe and effective. The lower cost is not a reflection of the effectiveness or safety of biosimilars. Both biosimilars and generics may offer more affordable treatment options to more patients.

Yes. If you are already using a biologic that works well, your provider might suggest that you change to a biosimilar, especially if it costs less. Sometimes prescription benefit plans may decide that they will only cover a biosimilar. The FDA has made sure biosimilars are as safe and effective as the reference product (original biologic). Biosimilars have the same treatment risks and benefits. Most are available in the same strength, dosage and device type as the reference product. 

Yes. Biosimilars can be used whether or not you have been treated with the reference product (original biologic). They may an appropriate treatment option to help manage your condition. Biosimilars are highly similar and have no clinically meaningful differences to the reference product. They have the same treatment risks and benefits. Biosimilars may cost less, and some prescription benefit plans may decide that they will only cover a biosimilar.

For example, if you have been recently diagnosed with rheumatoid arthritis, your provider might feel you could benefit from a specialty medication like Humira or a biosimilar for Humira. Biosimilars for Humira are highly similar and have no clinically meaningful differences than the reference product. Check with your prescription benefit plan to see which treatment options are covered.

It depends. Biosimilars may be more cost effective for you and provide additional access to treatment options. When there is more than one medication available to treat a condition, pricing usually becomes more competitive. However, the lower cost is not a reflection of effectiveness or safety. Like biologics, biosimilars require FDA approval. Biosimilars are highly similar and have no clinically meaningful differences from the reference product. Check with your prescription benefit plan to see which treatment options are covered.

There are many resources available for you to learn more about biosimilars. The best place to start is with Biosimilar Basics for Patients published by the FDA. Available in English and Spanish, the FDA has detailed content of what you need to know about biosimilars, including FAQs, infographics and education materials. Many non-profit foundations and patient advocacy groups have biosimilars resources specific to your condition – such as the Arthritis Foundation and Crohn’s & Colitis Foundation. Visit the CVS Specialty Patient Biosimilars Resource Center to connect with additional resources. You can also contact your provider or the CVS Specialty CareTeam.

Most biosimilars for Humira are FDA-approved for the same conditions as Humira, which include 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 for individual medications and pediatric uses. Check with your prescription benefit plan to find what medications are covered. Your provider or CVS Specialty pharmacist can help if you have questions.

No. Biosimilars for Humira are highly similar and have no clinically meaningful differences than the reference product (original biologic). That means you can expect the same safety and effectiveness from a biosimilar for Humira as you would with Humira. Every biosimilar is approved by the FDA. Biosimilars for Humira have the same treatment risks and benefits. Most are available in the same strength, dosage and device type as the reference product.

Depending on the biosimilar for Humira, strength and dosage, the medication delivery device may vary slightly but be similar to what you have used before. The biosimilar for Humira will either come in a pen, an autoinjector or a pre-filled syringe (PFS). All devices are easy to use and should be self-administered under the skin (subcutaneously). If you need additional support, we can connect you to the manufacturer for injection training videos and education. 

CVS Specialty has a specially trained CareTeam dedicated to supporting you as you transition to alternative medications, including biosimilars. Pharmacists and clinicians are available to answer your medication questions and help make the change as seamless as possible. You can also visit the Biosimilar Basics for Patients on the FDA website to learn more about biosimilars.  

It depends. If you fill your prescription for Humira at CVS Specialty and your prescription benefit plan has made a formulary change to exclude Humira, CVS Specialty will contact your provider to discuss alternative medications covered by your plan. Your provider can select the appropriate medication. No action is needed from you at this time.

It depends. If you already have a prior authorization (PA) for Humira, most prescription benefit plans will transition the existing PA to the covered alternative biosimilar for Humira. If your Humira PA has expired or your provider selects another therapy, then a new PA will be required. Contact your prescription benefit plan for more information. 

Yes. Most prescription benefit plans will notify you by mail 30-60 days before changes are made to the list of covered medications. The letter will inform you that Humira will no longer be covered, include covered alternative medications, and when the change will happen. CVS Specialty will contact your provider to discuss alternative medications covered by your plan. CVS Specialty will continue to fill Humira until the new medication coverage starts. After that, you will receive the alternative medication selected by your provider.

For those that have signed up for digital communications, you will receive notification that CVS Specialty has received a new prescription from your provider. You may also receive messages with links to biosimilar resources and how to contact us if you need support.

If you do not fill your prescriptions with CVS Specialty, contact your specialty pharmacy or your prescription benefit plan for additional information.

Yes. CVS Specialty CareTeam, with pharmacists and clinicians, is specially trained to support medication therapies for complex conditions and rare diseases. The CareTeam can give you the support you need and help you stay on track with your medications. They are also able to help you identify medication side effects, manage changes in benefits, and communicate back to your provider if needed. Visit our CVS Specialty Patient Resource Center to learn more about your condition or find education resources. If you need to connect with the CVS Specialty CareTeam, you can log into your CVSspecialty.com account and live chat with us.

For patients transitioning to a biosimilar for Humira, CVS Specialty has a dedicated CareTeam focusing on autoimmune conditions – such as rheumatoid arthritis, Crohn’s disease and psoriasis to name a few. They can help you understand what taking your medication will be like, what to expect and when to contact us or your provider. They can even connect you to the manufacturer for injection training videos and nursing support. 

If you are new to CVS Specialty, welcome. We do more than just provide specialty medications. With a personalized CareTeam, helpful digital tools and the choice of medication pickup or delivery, we are here to help make living with your condition a little easier. You can visit our Getting Started with CVS Specialty for helpful resources and to create an online account. Once registered, you can check order status and securely message your CareTeam. 

Yes, we recommend it. You can register at CVSspecialty.com or use our mobile app once you have received your first medication shipment. If you have not received your first medication shipment, you can pre-register at CVSspecialty.com/digital. With a CVSspecialty.com account, you will be able to sign up to receive text messages and emails. You must provide consent to receive digital communications. Along with receiving refill and shipping notifications, you can change a medication delivery or schedule an in-store pickup at any CVS Pharmacy®*. And if needed, you can securely message your CVS Specialty CareTeam.

It depends. Biosimilars may be more cost effective for you and provide greater access to treatment options. When there is more than one medication available to treat a condition, pricing usually becomes more competitive. Your out-of-pocket costs depend on a number of factors – such as your prescription benefit plan, its covered medications and what financial assistance programs are available.

Yes. Just like Humira, biosimilars for Humira have their own manufacturer patient support and copay assistance programs. CVS Specialty will proactively outreach to you when financial assistance may be needed or available. You can explore options available to you. If you know the biosimilar for Humira covered by your plan, visit the manufacturer website to see what financial assistance programs are available.

Yes. CVS Specialty can help connect you to financial assistance programs. If you’re approved for assistance, you typically qualify for one year. Some financial support has an amount limit and requires you to reapply annually. Funding criteria varies by manufacturer, organization, foundation and program. Payor requirements may affect eligibility and level of assistance.

Yes. Many non-profit foundations and patient advocacy groups have resources that can help you with out-of-pocket costs. These programs are designed to help the underinsured or uninsured afford medical treatment and medications. For example, the PAN Foundation has funds that cover more than 70 conditions. You can sign up for FundFinder and be put on a wait list or be notified when funding becomes available. If you need help navigating available resources, contact the CVS Specialty CareTeam. They can connect you to financial assistance programs through manufacturers, charitable organizations, discount programs and more.

Prescription benefit plans vary in how they deal with copay cards and patient assistance programs (PAP). Some count the copay toward your deductible or out-of-pocket (OOP) maximum. In these cases, your deductible and OOP costs may be less. Others have what is called a copay accumulator program. They do not count the copay card or PAP towards your deductible or OOP. In those cases, you may be responsible for paying the entire deductible and OOP amounts based on your prescription benefit plan. It is important to know how your plan deals with PAP and copay cards.