After Years of Slow Growth, Biosimilars are in Fertile Ground

Biosimilars: Affordable alternatives, but not ‘biologic generics’

To start, it’s helpful to note that biosimilars are biologics, which are medications derived from living organisms.[ref](https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers "What Are "Biologics" Questions and Answers, FDA, 2018")

Biosimilars are medications developed from living sources that are functionally equivalent to reference biologics, medications previously approved by the FDA. Unlike generic medications, biosimilars aren’t exact copies of their reference product due to natural variances in living cells.

Biosimilars face far more production costs and launch complexities than generics. Most generics are developed within two years and cost $1-2 million, compared to biosimilars, which can take five to nine years to develop and cost more than $100 million.^[4]Biosimilars vs. Generics: What's the Difference?, Pfizer, 2018

Despite these costs, the savings potential from biosimilars is significant.^[5]Biologics vs. small molecules: Drug costs and patient access, Makurvet, 2021

In one study, patients saved approximately $665 with a biosimilar versus a reference biologic compared to $86 in savings for generics compared to their reference drug.^[6]Biosimilars Competition Helps Patients More Than Generic Competition, USC Schaeffer, 2021 And with over half of patients in the last year giving up medications to pay for essential items, hundreds of dollars in savings could bring to life benefits beyond medications.^[7]CoverMyMeds Patient Survey, 2021

In fact, by 2025, greater biosimilar availability could help an estimated 1.2 million patients access more affordable biologic therapies for conditions such as rheumatoid arthritis, various cancers and plaque psoriasis.^[8]Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines, Biosimilars Council, 2017

Variations in the biosimilar landscape affect reasonable access

Launched and approved biosimilars in the U.S. represent over a third of current biologic spending, with predictions suggesting the biosimilars portion of the market will only increase.^[1]Biosimilars in the United States 2020-2024, IQVIA, 2020 But with such promise for patients, why'd this momentum take so long in the first place? As of 2020, only 19% of the biologics market had biosimilar competition, despite biosimilars being in the market since 2015.^[4]Biosimilars vs. Generics: What's the Difference?, Pfizer, 2018

Some studies show in 2016, half or more of physicians lacked knowledge or awareness of biosimilars, indicating a need for education.^[9]Factors Affecting Health Care Provider Knowledge and. Acceptance of Biosimilar Medicines: A Systematic Review, Leonard, 2019 In a 2021 study, nearly half of providers said they were waiting for biosimilars to be on the market longer before prescribing them.^[10]Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey, Kolbe, 2021

Providers are seemingly willing to overcome formulary management barriers to keep patients on a reference biologic. If only the biosimilar product were on a patient’s formulary, half of providers said they were likely or very likely to pursue a prior authorization for current patients successfully treated with a non-formulary reference product. However, if a patient hadn’t used the reference product, only 31% said they were likely or very likely to pursue a prior authorization.^[10]Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey, Kolbe, 2021

While biosimilars are usually cheaper than reference biologics, most patients still heavily rely on insurance coverage to help pay for their medications, and for this, drugs need to be on insurance formularies.

Access and future success for biosimilars hinges on negotiations with payers and pharmacy benefit managers (PBMs) who have shown inconsistent favorability of biosimilars over reference biologics.^[11]Five Takeaways from the Big Three PBMs’ 2022 Formulary Exclusions (rerun), Drug Channels, 2022 For FDA approval, biosimilars must prove similar effectiveness and safety to their reference products.

There are two burgeoning categories that could influence coverage likelihood and provider, patient and pharmacist trust: interchangeable biosimilars and authorized biologics. These distinctions could change pharmacy industry dynamics, prescribing habits and formulary management.

Interchangeable biosimilars are biosimilars that a pharmacist could substitute for a patient at the pharmacy without having to consult the provider who prescribed the brand biologic. To receive an interchangeable designation, these biosimilars must go through additional FDA evaluation and testing to ensure they replicate the reference product’s clinical results in any patient.^[12]Biosimilar and Interchangeable Products, FDA, 2017 The first two interchangeable biosimilars were approved by the FDA last year for diabetes and immunology, with more expected in the coming year.^[13]FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes, FDA, 2021

With 44% of patients turning to their pharmacists for affordability options, drugs with an interchangeable status can help pharmacists more easily address patient concerns without additional steps and approvals.^[7]CoverMyMeds Patient Survey, 2021,^[6]Biosimilars Competition Helps Patients More Than Generic Competition, USC Schaeffer, 2021

Authorized biologics are exact copies of the reference biologic developed by the reference biologic’s brand. Brands launch authorized biologics — sometimes known as unbranded biologics — to compete with biosimilars of the same molecule on the market. The first two authorized biologics launched in late 2021 for diabetes and immunology.

To get more affordable alternatives to brand biologics on the market earlier, some biosimilar companies may also pursue “skinny labeling.” In this method, companies introduce biosimilars that only list indications for which the reference drug’s use patents have already expired.

Action items for improved biosimilar adoption

Transparency, along with greater education, can help continue the momentum of biosimilars. Educational opportunities through the FDA, Department of Health & Human Services (HHS) and even biopharma and payers provide more accessible information about these therapy options.^[14]Curriculum Materials for Health Care Degree Programs | Biosimilars, FDA, 2021 Additional actions listed below will continue to be important as manufacturers introduce new biosimilars to the market and to formularies.

Increased and price and benefit transparency Greater attention to payer-PBM dynamics that impact the pricing of biosimilars and shining a light on market inefficiencies can result in better pricing for patients. Transparency is crucial to ensure access challenges don’t lead to abandonment and, therefore, weakened trust in these promising new medications. Solutions that can surface PA requirements at the point of prescribing can help start PA and reimbursement processes early in the medication access journey. PA-specific solutions can help patients access their medications 13.2 days sooner, on average.^[15]CoverMyMeds Integrated ePA, 2022 This can instill confidence in patients and can ease the process for care teams through improved transparency.

Greater provider awareness Healthcare providers need awareness about the availability of biosimilars, as well as their differences, substitutable versus interchangeable status and label variations. They need this information delivered in a user-friendly, objective manner to help dispel misinformation and increase prescribing comfort level for biosimilars. Patient-centric technology can help deliver this information. In one study of oncology patients, an EHR integrated with clinical pathways and financial information to surface appropriate biosimilars for patients who had been prescribed a reference biologic. Providers substituted a biosimilar for 83% of patients, resulting in an average 23% monthly cost savings.^[16]Successful biosimilar adoption in oncology: strategic approach to system standardization, Limvorasak, 2022 This study suggests using existing integrated technology can help introduce biosimilars to providers and patients and reduce overall medication costs.^[16]Successful biosimilar adoption in oncology: strategic approach to system standardization, Limvorasak, 2022

Bolstered patient support services Many biologics and biosimilars are complex medications that don’t follow the traditional administration route of a pill or a solution. In some cases, they require a visit to a clinic or an infusion center and can also require lab testing prior to treatment. As patients begin to make the switch from biologic to biosimilar, they can benefit from technology-enabled support services to ease the transition from clinical and logistical standpoints.

Read more about medication pipeline innovation, and how affordable options could help pateints in our 2022 Medication Access Report: Oncology Edition.