Exploring the Biosimilar Market Dynamics in the US Healthcare System

The growth of biosimilars in the United States has been a significant development in the pharmaceutical industry. According to BioIntel360, the United States biosimilar market size is expected to record a CAGR of 30.7% during 2023-2027 to reach US$11,316.0 million by 2027, increasing from US$3,879.6 million in 2023. Over the last five years, the sector has recorded a CAGR of 30.5%. The availability of biosimilars presents an opportunity to increase competition, improve patient access to affordable treatments, and reduce healthcare costs.

In recent years, the biosimilars market in the US has witnessed notable growth. Regulatory frameworks, such as the Biologics Price Competition and Innovation Act (BPCIA), have provided a pathway for the approval and commercialization of biosimilars. This has fostered an environment conducive to the entry of biosimilar products into the market several factors contribute to the increasing growth of biosimilars in the US. First, the potential for cost savings is significant. Biosimilars offer a more affordable alternative to reference biologics, which can result in substantial savings for patients, healthcare providers, and the overall healthcare system. Estimates suggest that biosimilars could save the US healthcare system billions of dollars over the next decade.

Second, the involvement of key stakeholders, including pharmaceutical companies, payers, and regulatory bodies, has been instrumental in promoting the adoption of biosimilars. These stakeholders recognize the potential benefits of biosimilars in terms of expanding treatment options, improving access, and driving competition.

Third, increased awareness and education about biosimilars among healthcare professionals, patients, and the general public have contributed to their acceptance and adoption. Efforts to inform and educate stakeholders about the safety, efficacy, and quality of biosimilars have helped build confidence and trust in these products.

The competition has also intensified as a result of new firms entering the biosimilars industry. The patients and the health care system as a whole ultimately gain from this competition's drive for innovation and price reduction. As more biosimilars gain regulatory approval and enter the market, the range of treatment options expands, providing patients with greater choices.

Samsung Bioepis, a biopharmaceutical company based in South Korea, has received a significant boost in its venture to enter the US market with biosimilars of Humira, the world's leading treatment for autoimmune diseases like rheumatoid arthritis. The company was initially expected to face challenges, but recent developments have brightened its prospects.
Hadlima, a Humira biosimilar manufactured by Samsung Bioepis, has been added to the formulary of Prime Therapeutics, the fourth-largest pharmacy benefit manager (PBM) in the United States. Regular patients in the US may be eligible for insurance reimbursement for Hadlima prescriptions as early as this month.
Additionally, Cigna Healthcare, a major American insurance company, also stated that Hadlima would be included in its formulary starting in September.
The biosimilar was introduced by Samsung Bioepis earlier this month, and according to industry estimates, it may be able to acquire a network that covers 10% of the US market. The company is not yet included in the formularies of two of the three largest PBMs in the United States, Express Scripts, Optum Rx, and CVS Caremark, which together account for 80% of the market.
PBMs and insurers serve as middlemen in the US medical insurance system, managing patient insurance coverage and dispensing medications. To determine insurance coverage, each organisation must give a list of medications and treatments.
Humira, with global sales reaching $21.2 billion last year, attracted the attention of world pharmaceutical giants such as Pfizer, Boehringer Ingelheim, and Sandoz Pharmaceuticals. These companies simultaneously launched biosimilars of Humira after AbbVie's patent on the drug expired late last month.
Utilising its expertise and success in Europe as well as its affordable price, Samsung Bioepis is anticipated to grow its market share in the US with its high-concentration goods. The US Food and Drug Administration has given its high- and low-concentration biosimilars the go-ahead.
To gain a foothold in the US public insurance market, which will eventually open up, the company sells Hadlima at an 85% discount compared to Humira, implementing a strategic pricing approach.
With these recent developments and its strong track record, Samsung Bioepis is poised to strengthen its position in the US market, paving the way for increased accessibility to affordable biosimilar treatments for patients in need.
Express Scripts has taken a significant step towards driving affordability and increasing patient access in the realm of inflammatory disease treatments. The company recently announced the inclusion of three additional biosimilars on its National Preferred Formulary (NPF), further expanding the range of cost-effective options available to patients and physicians.
The newly added biosimilars include Cyltezo and both Sandoz products, namely Hyrimoz and unbranded adalimumab-adaz. These biosimilars, known for their competitive net costs, will now be listed as preferred products alongside HUMIRA, the world's top-selling pharmaceutical drug, on the NPF.
The inclusion of these biosimilars aligns with the potential of such medications to generate substantial savings for the U.S. healthcare system. According to estimates, biosimilars can save up to $375 billion in total pharmacy expenditure over the next ten years. By embracing these cost-saving alternatives, Express Scripts demonstrates its commitment to driving greater affordability for its clients and improving the overall healthcare landscape.

However, it is important to note that the growth of biosimilars in the US still faces challenges. Market exclusivity, patent litigation, reimbursement policies, and regulatory complexities are some of the factors that can impact the uptake and market penetration of biosimilars.

BioIntel360 suggests that the growth of biosimilars in the US is a promising development for the healthcare industry. With their potential to increase competition, improve patient access, and reduce costs, biosimilars can transform the treatment landscape. Continued efforts to address challenges and promote the adoption of biosimilars will contribute to a more sustainable and accessible healthcare system in the United States.