With the global market for biologics estimated at $382 billion just last year, and a projected global drug spend of close to $1.5 trillion by 2027, the landscape is ripe for biosimilars to help decrease the health care system’s cost burden.
By 2027, drug spend on oncologic agents is expected to be approximately a quarter of the global drug spend for the year, with a compound annual growth rate (CAGR) of 13% to 16%. Drug spend for immunological conditions and diabetes run a close second, followed by therapeutics for cardiovascular, respiratory, central nervous system, and infectious diseases; genitourinary sexual health; gastrointestinal conditions; mental health; pain; HIV; ophthalmological, musculoskeletal, and dermatological conditions; and blood coagulation. Lipid regulators, vaccines (not including flu or COVID-19), treatments for obesity, and cough, cold, and flu vaccines and antivirals round out the list.
Obesity, especially, is another area expected to have a high CAGR by 2027: 12% to 13%.
As recently as last year, the global market for biologics was estimated at $382 billion.
Such statistics are how Timothy Mok, PharmD, BCPS, BCOP, kicked off the session “Biosimilar Operational Readiness: Current and Future Market Landscape” at AMCP 2023. Mok is a hematology oncology pharmacy research analyst, Clinic Administered and Specialty Medications, Kaiser Permanente Drug Use Management, and assistant clinical professor at the University of California San Francisco. The goals of this session were to define biosimilar use framed by managed care, formulary considerations for the current market, and strategies to increase biosimilar uptake in the space.
“Who likes to go shopping?” Mok asked the crowd, “Because we are going to be spending a lot of money.” Extrapolating through 2026, Mok presented data showing a steady rise in oncology drug spend: from approximately $56 billion in 2011 to $300 billion in 2026, $129 billion of which is biologics and $12 billion, biosimilars.1,2
“I know the biosimilar spend may seem small, but we all know things that are small can also be mighty, and can also grow. So, the projected annual growth rate is 30%. It’s growing better than our stock market,” Mok said. “Physicians, too, are much more ready, much more okay to use biosimilars than they were before.”
The landscape is ripe, therefore, for biosimilars to help decrease the drug spend cost burden, not only for health care overall, but on the part of payers and patients, too, he emphasized.
Comparing existing biologics to biosimilars, Mok laid out several advantages of biosimilars, including that they are biologics; they are highly similar to existing FDA-approved reference products in their living source materials (ie, structure and biologic activity), administration, strength, dosage, potential effectiveness, and likely adverse events; and they have no clinically meaningful differences from reference products.
In addition, the complex discovery and manufacturing process of many biologics contributes to their ultimate high drug cost, with Mok underscoring that their extensive research and development includes ensuring adequate delivery systems that will not interrupt or disrupt the drug’s protein structure. Biosimilars, however, present price competition and increase patient treatment access.
One specific example he provided was rituximab. When the first rituximab biosimilar came out, rituximab-rbbs (Truxima), there was an approximate 5% difference in average sales price (ASP) from the reference product. Subsequent biosimilars, rituximab-pvvr (Ruxience) and rituximab-arrx (Riabni) saw prices decreases of approximately 20% and 17%, respectively, Mok explained. In addition, corresponding reductions from the wholesale acquisition costs were 10%, 24%, and 24%.3
Another example is infliximab. Using 2015-2022 data, Mok showed a trend toward decreasing prices beginning in 2016. That year, Inflectra (infliximab-dyyb) was introduced, and it was followed by Renflexis (infliximab-abda) in 2018 and Avsola (infliximab-axxq) in 2020. There were slight price increases from 2016 to 2017 and 2021 to 2022 for reference infliximab and Renflexis, respectively,4 but overall, “as more biosimilars came to market, we started seeing a decrease in price,” Mok said.
The Biologics Price Competition and Innovation Act, passed by Congress in March of 2010, is a big part of the push to widen the use of biosimilars, he noted, with legislation that will “allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).”5 This also helps to avoid duplication of development efforts, thereby lowering the need to conduct human and animal testing.
Biosimilar availability also lends itself to more opportunities for substitution at the pharmacy level, similar to how generic products are substituted for brand name medications. However, in order for one biosimilar to be substituted for another without requiring physician permission, it has to have an interchangeability designation from the FDA. To obtain interchangeability, most products, excluding insulins and ophthalmology products, companies are required to conduct additional clinical trials—after which pharmacists can automatically substitute them for the reference product, provided state laws allow it.6
Biosimilars alone are projected to have global savings of up to $150 billion by 2027.7 So, why is there still holdup to their wider implementation?
Mok noted 3 principal problem areas:
To enhance biosimilar adoption, he noted the importance of properly educating both patients and providers, of incorporating utilization review by way of identifying high-cost biologics that have biosimilar alternatives and considering policy reviews for therapeutic substitution, and leveraging a combination of information technology and contracting, which can help to facilitate selection of preferred biosimilars, based on contracting, and offset the burden of the ordering prescriber to align their prescribing.
1. Global oncology trends: outlook to 2026. IQVIA. May 26, 2022. Accessed April 5, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/global-oncology-trends-2022
2. Oncology biosimilars global market report 2022: by drug, by cancer, by distribution. ResearchandMarkets. March 24, 2022. Accessed April 5, 2023.https://www.researchandmarkets.com/reports/5553685/oncology-biosimilars-global-market-report-2022
3. Medicare Part B drug average sales price. CMS. Updated January 4, 2022. Accessed April 7, 2023. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice
4. Dr Ivo Abraham column: when more may yield less—price erosion of biosimilars following US market entry. The Center for Biosimilars. September 26, 2022. Accessed April 7, 2023. https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-when-more-may-yield-less-price-erosion-of-biosimilars-following-us-market-entry
5. Biologics Price Competition and Innovation Act of 2007, S.1695, 110th Cong (2007). Accessed April 7, 2023. https://www.congress.gov/bill/110th-congress/senate-bill/1695
6. FDA interchangability designation. Boehringer Ingelheim. Updated December 2022. Accessed April 7, 2023. https://www.boehringer-ingelheim.com/us/interchangeability/fda-designation
7. Global use of medicines 2023. IQVIA. January 18, 2023. Accessed April 7, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicines-2023