Biosimilars

Biosimilars are not generic versions of a biologic.

Generic medicines are created to work the same way and provide the same benefits as the original name-brand medicine. The active ingredients in generic medicines are an exact copy of those in brand-name medicines but may contain different inactive ingredients, such as color or flavorings.

Biologic products are more complex. Biosimilars and their reference products are made from living systems and as a natural part of the manufacturing process, minor variations can occur. These variations make it impossible to create exact copies, and minor differences are expected between batches (and within batches) of the original reference product and biosimilars. In order to be FDA-approved, biosimilars must demonstrate the same safety and effectiveness as their reference product. This means there are no clinically meaningful differences between biosimilars and their reference product, even if they are not exact copies.

Biosimilars and interchangeable products go through an FDA approval process to ensure they are just as safe and effective as their biologic reference product. Although biosimilars are modeled after their biologic reference product, they go through different approval processes than biologic treatments.

All biologics, including biosimilars:

• Target specific parts of the immune system rather than impacting the entire immune system
• Are given as an injection or IV infusion

To be approved as a biosimilar for a particular reference biologic, the biosimilar must be:

• Highly similar to the reference product and cannot have any clinically meaningful differences in terms of safety or efficacy
• Approved for the indication(s) and condition(s) for which the reference product is approved
• Given the same form and in the same dosage as the reference product

Keep in mind that biosimilars are not exact copies of their biologic reference product. Biologics are large and complex molecules from living sources that cannot be exactly copied (including from batch to batch).

The biologic reference products below have the following biosimilars that are FDA-approved for the same indications.

Enbrel (etanercept): Approved for psoriasis and psoriatic arthritis

• Erelzi (etanercept-szzs)
• Eticovo (etanercept-ykro)

Humira (adalimumab): Approved for psoriasis and psoriatic arthritis

• Abrilada (adalimumab-afzb)
• Amjevita (adalimumab-atto)
• Cyltezo (adalimumab-adbm)
• Hadlima (adalimumab-bwwd)
• Hulio (adalimumab-fkjp)
• Hyrimoz (adalimumab-adaz)
• Idacio (adalimumab-aacf)
• Yuflyma (adalimumab-aaty)
• Yusimry (adalimumab-aqvh)

Remicade (infliximab): Approved for psoriasis and psoriatic arthritis

• Avsola (infliximab-axxq)
• Inflectra (infliximab-dyyb)
• Ixifi (infliximab-qbtx)
• Renflexis (infliximab-abda)

Stelara (ustekinumab): Approved for psoriasis and psoriatic arthritis

• Wezlana (ustekinumab-auub)

All biologics, including biosmilars, are typically prescribed for people with more advanced disease, including individuals with moderate-to-severe psoriasis and active PsA. Each of the approved biosimilars is indicated for different groups within this population.

Consult your health care provider before taking a biosimilar if:

• Your immune system is significantly compromised
• You have an active infection

Screening for tuberculosis or other infectious diseases is required before starting treatment with all biologics, including biosimilars.

The risks and side effects of biosimilars are the same as those associated with their biologic reference product. Anyone considering taking a biosimilar should talk with their health care provider about the short- and long-term side effects and risks. It is important to weigh the risks against the benefits.

Biologics and biosimilars can increase the risk of infection. If you develop any sign of an infection, such as a fever, cough, or flu-like symptoms, you should contact your health care provider right away.

It is important to tell your health care provider about all treatments, medicines, vitamins, or supplements that you are taking. Like all biologics, biosimilars can be used with other treatment options including topicals and phototherapy.

An interchangeable biosimilar must meet the biosimilar standard plus additional standards outlined by law. If a biosimilar is approved as interchangeable, a pharmacist may substitute it for the reference product without asking your prescribing health care provider. Most states have added additional guardrails around pharmacy-level substitutions.