Arthritis Foundation Statement on Biosimilars

ATLANTA, August 18, 2022 — Biologics are game changers for managing autoimmune diseases. There are two groups of biologics: reference products (or original biologics) first introduced in the 1990s and biosimilars (versions of reference products) first introduced in the 2010s in the United States. Biosimilar medications are increasingly becoming available for people with arthritis as patents expire for reference products like infliximab ( Remicade ) and adalimumab ( Humira ). The Food and Drug Administration (FDA) requires biosimilars to have “no clinically meaningful differences” from their reference product.

As more biosimilars become available to patients, the Arthritis Foundation believes that:

• Biosimilars are safe and effective per the FDA approval standards and current data.
• The decision to use a biosimilar should occur between the patient and the provider.
• Every health care stakeholder holds responsibility in educating and communicating with patients about biosimilars.
• Health plans should provide timely notifications and updates to patients about biosimilar policies and formulary changes.
• Patients who use biosimilars should benefit from out-of-pocket cost savings and receive cost-sharing protections, including but not limited to the use of co-pay assistance.

Background

Biological products (or biologics) are a type of disease-modifying antirheumatic drug (DMARD) used to treat autoimmune and inflammatory types of arthritis and other conditions. They are large, complex molecules created from living organisms and target specific parts of the immune system that fuel inflammation. There are two groups of biologics: original biologics (or reference products) and biosimilars. Reference biologics may be offered under a brand name or unbranded (i.e., without the branded packaging and labeling).

Biosimilars are FDA-approved versions of reference biologics. They are not generics. Biosimilars are highly similar to reference biologics with no clinically meaningful differences in purity, safety, and effectiveness. However, they are not identical to reference products. Creating exact copies of reference biological products is not possible because they are made from living organisms, which are unique and complex. Biosimilars are also made from living organisms.

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 ensures that biosimilar medications must meet rigorous criteria before being FDA-approved. Biosimilars and reference products are both developed from living organisms, have similar molecular structures, and must meet the FDA’s strict standards for quality and consistency. A reference product and its biosimilars are offered at the same strength and dosage and use the same modes of administration, i.e., by self-injection or via infusion in a health care facility. Biosimilars are manufactured in FDA-licensed facilities.

The first biosimilar for autoimmune arthritis — Inflectra , whose reference product is Remicade — was approved by the FDA in 2016 and entered the market in 2017. A growing number of approved biosimilars for the arthritis reference biologic Humira are expected to become available when the Humira patent expires at the beginning of 2023. Biosimilars for Enbrel are expected when its patent expires, which is anticipated in 2026.

Importantly, the BPCIA also includes a provision called “interchangeability.” This permits states to enact laws that allow pharmacists to exchange reference biologics for biosimilars without health care provider approval. To receive the interchangeability designation, a biosimilar manufacturer must demonstrate no increased safety risk or reduced effectiveness when a patient switches multiple times between the reference product and the interchangeable biosimilar.

The Issue

Competition from biosimilars has the potential to lower medication costs and make biologics more accessible. A 2019 analysis by the Kaiser Family Foundation found that the average annual out-of-pocket costs for two reference biologics commonly used for arthritis is $5,000 among Medicare Part D enrollees with no low-income subsidies. Biosimilars are expected to cost on average 30% less than their reference products, and some analyses show they could save the U.S. as much as $54 billion over a 10-year period.

However, there are several reasons why the availability of biosimilars may not increase access or affordability of medications.

Potentially varying treatment preferences by patients, insurers and health care providers explain one set of challenges. A 2020 study published in the Journal of the American Medical Association involving 535 coverage decisions from 17 of the largest commercial health plans showed only 14% had biosimilars as the preferred product over branded reference biologics. (Preferred products tend to have lower cost-sharing and/or administrative requirements.) It also showed biosimilars were the non-preferred product in 33% of cases and they were on par with reference biologics in 53% of cases. Other reports indicate various levels of misleading information and confusion among other stakeholders like employers , adding additional potential barriers to biosimilars adoption.

Patient trust and comfort levels explain another set of challenges. A recent Arthritis Foundation survey and accompanying focus group data indicate that patients may be reluctant to use biosimilars if:

• They have limited or no knowledge about them.
• Their doctor has not talked to them about biosimilars as a treatment option.
• They fear biosimilars will not work as well as their original biologic.
• They may not have easy access through their formulary.
• Their out-of-pocket costs may not be significantly lower.

Lastly, there is confusion over data. Statements that detail the side effects and risks of switching do not always use apples-to-apples data, sometimes referencing adverse-event data about switches from one reference biologic medication to another reference biologic medication, rather than switches from a reference biologic to its biosimilar.

Above all, many patients who are currently stable on their drug may be fearful about transitioning. This fear persists regardless of a medication being “clinically equivalent” or data that indicates it’s safe to switch from reference biologics to their biosimilars.

We recognize that payer formularies may require stable patients to transition. Unfortunately, some patients have learned about such requirements from a letter in the mail rather than through a conversation with their health plan or provider, often leaving them with questions and confusion. Since there are multiple biosimilars for any given reference product, patients could be required to switch between multiple biosimilars even within a calendar year.

There are also specific concerns and considerations for our pediatric population. Parents of pediatric patients have indicated they want to know if biosimilars have been studied in children with uveitis and juvenile arthritis, in addition to practical questions like whether the injection devices will be the same, whether the needle sizes are comparable, and whether the medications will be citrate-free. (Citrate is an additive which causes the injection to be painful.) The Arthritis Foundation will continue to gather information about biosimilars and the pediatric population and will update this statement accordingly.

Solutions for Increasing Patient-Centered Biosimilars Use

Increasing the use of biosimilars to help lower costs and make them more accessible must focus on patient incentives, ensuring access through formulary policies, and communication that avoids bias or misinformation, including addressing the fear of “the new” and providing information about safety and effectiveness.

While we believe that biosimilars are safe and effective per the FDA approval standards and current data, patients and providers should be core partners in treatment decisions.

Every stakeholder in the health care ecosystem has a distinct responsibility for ensuring a patient-centered approach to incorporating biosimilars into patient care. There are some cross-cutting recommendations for all stakeholders throughout this section, including:

Using FDA recommendations and language as a model in external and patient-facing materials for consistency, to explain complex concepts and to help avoid any biases; and

Utilizing best practices for patient-facing communications about biosimilars.