Luke Halpern

Biosimilars can lower drug costs and improve access, but provider hesitancy persists due to efficacy and safety concerns.

FDA interchangeability designation allows pharmacists to substitute biosimilars, but state regulations vary, requiring careful navigation.

Pharmacists must manage insurance coverage complexities and educate patients on biosimilar options and financial assistance programs.

As more biosimilars gain FDA approval, pharmacists' roles in selection, compliance, and patient education will expand.

This article was originally published by 

The proliferation of biosimilars, which has accelerated in recent years, has the chance to lower the cost of prescription drugs across countless conditions for millions of individuals. Medications for chronic diseases are often coupled with significant price tags and cause long-term financial stress, which makes managing the conditions even more burdensome. Not only can biosimilars reduce prices for myriad drugs, but they can also improve patient access to medications and make prescribing easier for the pharmacist.

Pharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications. | Image credit: sebra - stock.adobe.com

Still, many providers harbor a reluctance to prescribe biosimilars because of their lack of comfort with their efficacy or safety compared with a reference biologic. There are also complex hurdles and restrictions created by the FDA regulating the use of biosimilars, which can make it difficult for patients and providers to understand which treatments are available for them and at what price.

The ability to designate biosimilars as “interchangeable” (those that demonstrate enhanced clinical similarity with a reference product) has allowed pharmacists greater flexibility. Still, interchangeability rules vary by state and only apply to a handful of treatments. Pharmacists must educate not only themselves but other members of the patient care team as well as patients on regulations, feasibility, and processes surrounding biosimilar substitution.

Interchangeable biosimilars must satisfy multiple conditions to be automatically substituted for an original reference biologic. The conditions include the following

It must be a biosimilar approved by the FDA.

It must produce the same clinical outcomes as the reference product in any patient for any approved indication.

If a biosimilar is given more than once to the same patient—whether switching or alternating with the reference product—it must sustain similar efficacy and have no greater risk of adverse events.

Although the FDA is responsible for deeming biosimilars interchangeable, it is the responsibility of pharmacists to properly select biosimilars they know are available and as effective as the reference biologic.

States have varying regulations surrounding the automatic substitution from a reference biologic to an interchangeable biosimilar. However, the FDA allows pharmacists to substitute a reference product without the approval of a prescribing physician. Despite the lack of uniformity, 46 of the 50 states allow for that FDA standard (the exceptions are Alabama, Indiana, South Carolina, and Washington).

 Pharmacists should ensure they are complying with specific state laws regarding biosimilar interchangeability and maintain sustained communication and accurate recordkeeping at an individual patient level.

Pharmacists cannot freely substitute a reference biologic for a biosimilar product without an FDA interchangeability designation. These cases require that a prescription for the biosimilar is written specifically by a prescriber, indicating it is safe to switch from the reference product. Proper awareness of which medications are considered interchangeable is an essential component of pharmacist biosimilar management.

Navigating insurance coverage is another critical aspect of biosimilar prescribing. Insurance companies typically provide coverage for biosimilars, but pharmacists should ensure they understand all relevant individual considerations for a patient’s coverage of biosimilars. Some factors to consider when deciding on a biosimilar for a patient are the type of insurance plan the patient is enrolled in and their formulary coverage, which can significantly affect biosimilar eligibility.

Pharmacists can consult directly with plan providers for patients on Medicare and Medicaid to discuss their eligibility for biosimilar coverage. Beyond communicating directly with insurance providers, pharmacists can educate and empower patients regarding manufacturer co-pay cards and programs to help patients pay for their insurance, which could help reduce the financial burden that may be associated with the cost of biosimilars.

Choosing which biosimilar to use for a patient’s condition can be challenging. Pharmacists in all spaces, whether community or health system pharmacists, should educate themselves about the biosimilars that have been approved by the FDA thus far as well as those that are further down the pipeline but expected to become available. Pharmacists can review resources to stay current on approved biosimilars of proven indications and can provide important input into decisions regarding the proper use of biosimilars in health facilities.

With a unique position as members of the patient’s multidisciplinary team, pharmacists can appropriately evaluate biosimilars based on each patient’s concerns and requests. Pharmacists in the clinical setting can provide a holistic view of the biosimilar products’ clinical profile and other important considerations, including proper storage, shelf life, and other aspects relating

Pharmacists play an important role in the substitution of biosimilars and patient education surrounding their use. The role of pharmacists in this space will only continue to grow as more biosimilars gain FDA-approved interchangeability status.

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Pharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications.

As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are Paramount

Before a once-in-a-generation pandemic struck the globe, adalimumab (Humira; AbbVie) was the most profitable drug in the world; however, the pandemic led to it being surpassed by Pfizer’s COVID-19 vaccine.

 Over the past decade, this anti-inflammatory drug reigned in billions of dollars in profits for the company, and it has become one of the best-selling drugs of all time.

All biologic drugs, including biosimilars, are developed using cell processes, resulting in each batch and product to have slight structural differences. These structural differences do not alter the safety or efficacy of the product but are the reason why biosimilars are not labeled as generic drugs, which are exact copies of the original molecule. Image credit: 

However, that was then—and now, biosimilars are poised to significantly change the trajectory of the drug’s profit margin, as well as that of other biologic drugs, which could subsequently alter the financial landscape of the entire pharmaceutical industry.

Before the arrival of adalimumab biosimilars on the market, AbbVie attempted to prevent its presence on the market by filing hundreds of patents and waging aggressive litigation against rival companies. However, exclusivity because of this ongoing litigation is now expiring, and 9 Humira biosimilars have been FDA-approved and 8 have entered the market.

Interchangeable biosimilars are a new frontier in this burgeoning industry. This allows a patient obtain a biosimilar in place of a reference product without the pharmacist having to get approval from a physician first, making biosimilars more accessible and convenient for patients.

For a biosimilar drug to be designated as interchangeable, there is a long process of deliberation and investigation. In most cases, the manufacturer must go through extra trials in which patients are switched back and forth between a biosimilar and its reference product repeatedly to ensure that efficacy and safety remains unchanged between the drugs.

Perhaps that is why there are currently only 4 biosimilars with the interchangeable label, one of which being an adalimumab product (Cyltezo; Boehringer Ingelheim). However, the current lack of interchangeable biosimilars on the market has been found to cause delays in care and worsen quality of life for patients who need to wait for a physician to approve a biosimilar for a prescription because of the potential cost savings.

Interestingly, interchangeability distinctions don’t exist in Europe, and the biosimilar industry has been open for many more years than in the United States. In fact, the launch of biosimilars across the European Union led to a 44% increase in patient access to these products.

Legislation has recently been proposed that would eliminate the strict interchangeability requirements in place for biosimilars and undoubtedly change the burgeoning industry. However, it remains to be seen how it would affect manufacturers, patients, and pharmacists.

The flurry of congressional action over biosimilars began in early 2021. In April of that year, President Biden signed the bipartisan Advancing Education on Biosimilars Act, which calls for the federal government to disseminate educational materials, such as infographics, webinars, and educational programs, to treatment providers and the public to increase knowledge about their existence and value.

Although not directing explicit actions from the government, the bill intended to spur faster progress by the FDA in approving biosimilars. Notably, the first biosimilar was approved in 2015 only after Congress had passed another bill in 2010, the Biologics Price Competition and Innovation Act, which created a pathway to approval for biosimilars.

More recently, the Inflation Reduction Act was enacted in October 2022. One of the provisions of the bill allows for the CMS to provide a 2% reimbursement increase for using qualified biosimilars to entities covered by Medicare Part B over the next 5 years.

The incentive is designed to encourage outpatient infusion centers to use biosimilars instead of reference biologic products, which will increase the prevalence of biosimilars and increase market competition. As of last October, there were 15 qualifying biosimilars that are eligible to receive the 2% reimbusement bump.

Now, Senator Mike Lee (R-Utah) has proposed the Biosimilar Red Tape Elimination Act in the Senate. The bill, according to a press release by the senator, “would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA,” and allow switching studies “in special circumstances.”

Furthermore, the bill would “require the FDA to conduct a private briefing with relevant committee heads if the agency wants to require a switching study.”

 Suffice to say, the passing of this bill could dramatically alter the biosimilar landscape and potentially lead to a flurry of approvals, new legislation to improve access and encourage implementation, and possible litigation from a litany of drug companies behind reference products.

What Does the Future Hold for Patients and Pharmacists?

With all of this passed and proposed legislation, it makes sense to pause, reflect, and consider the impact that may be felt on dozens of manufacturers, millions of patients, and the thousands of pharmacists who treat and prescribe these biosimilars.

The variety of legislation that has been passed or proposed, in combination with an overall increase in the awareness of biosimilars, is ramping up the market. The biosimilar industry has grown 12.5% annually, on average, over the past 5 years and makes up 46% of spending. Additionally, competition fostered by biosimilars may save between $225 billion and $375 billion in total US pharmacy spending over the next decade.

, Ron Lanton III, JD, discussed the impact of Senator Lee’s legislation on the biosimilar market, which he said, “would align the United States with the European Union and help to accelerate the approval and use of biosimilars.”

In terms of pushback from reference drug companies looking to protect their million-dollar investments, Lanton downplayed the possibility.

“Now that many of the same companies have biosimilars of their own reference drugs, I doubt there will be much pushback,” Lanton said.

He explained that now that there is more information available and the FDA has a process that can be merged into a single application, “the concern is unwarranted.” Lanton added that biosimilars can significantly reduce the costs of lifesaving cancer treatment, but this will only occur if physicians and pharmacists become more educated and teach their patients about the benefits of biosimilars.

“Much like when patients were weary of generics when they were first introduced, even with the substitution of biosimilars, more education to the public of their effectiveness will need to happen in order to have significant adoption which will result in more savings,” Lanton said.

Fran Gregory, vice president of emerging therapies at Cardinal Health, agrees with this sentiment. With the new wave of biosimilars incoming, pharmacies will increasingly play a bigger role in distributing these new drugs to patients.

“It is critical for pharmacists to not only be confident in the clinical efficacy and safety of the biosimilar, but also to help instill confidence in the patient,” Gregory explained during an interview with 

Beyond offering confidence and clarity regarding biosimilars, Gregory notes that the responsibility of pharmacists extends to ensuring that inventory of products are available and having a knowledge of multiple variations of products to ensure that patient preferences are considered.

What about the interchangeability controversy?

“The concerns with interchangeability are valid,” Gregory said.

She mentions that there is a significant extra cost in the development of biosimilars, and that most likely will be reflected in the price of the drug once it launches.

“The interchangeability designation is an unnecessary extra cost and may delay the value and cost savings that biosimilars promise,” Gregory said.

Overall, despite constricting interchangeability regulations and a trickling of approvals up to this point, Gregory feels the future of biosimilars is bright.

“We are still in the beginning stages, and there is much more to come,” she said. “Biosimilars will continue to bring value to patients and lead to a more sustainable health care system.”

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S. 164 – 117th Congress (2021-2022): Advancing Education on Biosimilars Act of 2021. (2021, April 23). Accessible at 

https://www.congress.gov/bill/117th-congress/senate-bill/164#:~:text=This%20bill%20requires%20the%20Food,of%20biological%20products%20and%20biosimilars

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https://www.pharmacytimes.com/view/here-are-7-key-facts-about-biosimilars

Adam KC, Nuernberger C, Govindgari S. President Biden signs legislation boosting generic and biosimilar drugs. White & Case. May 3, 2021. Accessed August 24, 2023. Accessible at 

https://www.whitecase.com/insight-alert/president-biden-signs-legislation-boosting-generic-and-biosimilar-drugs

Schneider S, PharmD, BCPS and Desai N, MBA, BS, RPh, CPPS. Capitalize on biosimilars: understand the Inflation Reduction Act. Pharmacy Times. May 23, 2023. Accessed August 24, 2023. Accessible at 

https://www.pharmacytimes.com/view/capitalize-on-biosimilars-understand-the-inflation-reduction-act

Mike Lee, US Senator for Utah. Lee seeks increased competition in biological drug market. Press release. July 13, 2023. Accessed August 24, 2023. Accessible at 

https://www.lee.senate.gov/2023/7/lee-seeks-increased-competition-in-biological-drug-market

Jeremias S. Senator reintroduces Biosimilar Red Tape Elimination Act. AJMC, The Center for Biosimilars. July 14, 2023. Accessed August 24, 2023. Accessible at 

https://www.centerforbiosimilars.com/view/senator-reintroduces-biosimilar-red-tape-elimination-act

Antrim A. Biosimilars increasingly being added to PBM formularies. Pharmacy Times. July 13, 2023. Accessed August 24, 2023. Accessible at 

https://www.pharmacytimes.com/view/biosimilars-increasingly-being-added-to-pbm-formularies

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.

Luke Halpern

As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are Paramount

The Growth of Biosimilars Continues to Create Hope for Lower Drug Costs