Biosimilars: The Future of Affordable Biologic Therapies
Biologics are some of the most expensive forms of therapy in modern healthcare. These high prices are the result of multiple factors: they’re derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and they’re in high demand without much competition. Prices can range anywhere from $3,000 a year for asthma, eczema, and allergy treatments to $100,000 or more per year for certain cancers. While biologics only account for 2% of overall prescriptions, they contribute to 37% of net drug spending [1]. This can make these treatment options much less accessible to the general public as it forces many healthcare professionals and insurance companies to rule them out for cheaper, possibly inferior, formulations. However, there are products that can help bridge the affordability gap created by these biologics, while also providing similar efficacy and safety for patient treatment.
The Cost-Saving Alternative: What are Biosimilars?
Biosimilars are biologic formulations that are very similar to a reference biologic product already approved by the FDA. Biologic products can’t be recreated exactly because of the inherent variation that exists within living organisms that biologics are derived from. Therefore biosimilars are formulated in such a way that there are no clinically meaningful differences between each biosimilar and their reference product in terms of safety, efficacy, and potency, and the FDA does rigorous testing and evaluation to ensure this before approval. [2]
Some biologics are very effective treatments for specific disease states like autoinflammatory disorders, and some may be the best known treatments for those conditions. However, the high prices of these patented formulations make it difficult for patients to gain access to the best possible treatment for their condition. Some products may be too costly for insurance to cover, while others might require use of other medications first or even prior authorizations that need approval before giving access to patients. The existence of biosimilars is meant to address both the cost and access of biologics in the healthcare industry. [1][2]
Fortunately biosimilars are much less expensive than their reference product and multiple biosimilars can be created for one reference biologic by different companies, making these formulations more easily accessible to patients. Also, since the biosimilars are evaluated to have similar safety and efficacy to their base product, healthcare providers can feel safer prescribing these formulations, knowing that their patients are receiving the most effective regimens without having to worry as much about their cost. Insurances would be more willing to cover those prices and give lower copays for patients thanks to the improved cost-effectiveness of these formulations, as well as the fact that more hospitals would be able to place them on their formularies due to better accessibility and lower costs. [1][2]
The Challenges of Biosimilars
While biosimilars seem like an obvious answer to this pricing and accessibility issue with biologics, their existence doesn’t automatically warrant their use or a secure place for them in the market. The approval of new biosimilars and the process of finding a place for them in the healthcare space will have its own set of challenges:
- Physician Trust: Biologics are more well-known and trusted by physicians who have been exposed to them for years. Newer biosimilars and even possibly their manufacturers will not enter the market with that same trust to use their product. Companies will have to make an effort to communicate with these healthcare professionals, informing them of their product and helping them feel more confident in recommending it to their patients.
- Market Competition: Another similarity that biosimilars have to generics is that there can be multiple biosimilars for the same reference product, leading to competition for shares in the market. Without good advertising or a strong market presence, these biosimilars can easily be overlooked and not see as much use.
- Lack of Post-Market Data: Very new biosimilars will have little to no post-market reports of their use once approved by the FDA. This makes it challenging to recommend as many HCPs may not want to take what they see as a risk with this product if it hasn’t seen official use in the market yet.
Biosimilars don’t have a predetermined path to use in treatments once they’re approved by the FDA, but proper communication with physicians and establishing their presence in the market can help them find their place in the healthcare system. Newer or less prominent manufacturers will struggle the most with these challenges, but there are teams with the experience and tools to overcome these obstacles and get more biosimilars into the pharma market.
Pharma Companies and Biosimilars
Pharma companies with established products and who have already formed connections with healthcare professionals can overcome some of these challenges and they have the resources to accrue this data and present it properly to physicians. In fact, 50% of the global market for biosimilars is dominated by large pharmaceutical companies such as Pfizer, Sandoz, and Amgen, who are known to have worldwide reach and top of the line research and development capabilities to maximize market access. [4]
One example in the United States is Samsung Bioepis, a biopharmaceutical company whose mission statement is to accelerate access to biologics by “bringing high-quality, clinically proven biosimilars to patients who need them.” The company was able to launch 41 new biosimilars into the US market during 2024. Their biosimilar market trends over 2024 have shown a 53% average increase in market share within 5 years post launch of each product, while average sale prices also decreased by around 53% within 5 years. [3]
In terms of worldwide growth, the global market value for biosimilars has increased consistently over the last 5 years. Starting in 2019, the US market was valued at $4.5 billion and the European market at $7 billion, as the two nations led this growth to $9.3 billion and $13 billion in 2023, respectively. The global biosimilars market is projected to grow beyond $68 billion by 2028, as more biologic patents are set to expire and generic manufacturers are expected to enter and evolve the market with their business practices. [4]
Pharma or BioPharma companies would also benefit from having certified professionals equipped with expertise in biologics and biosimilars to take this information, apply it to further research, development, and marketing, and communicate it properly to healthcare professionals. A Board Certified Biologics and Biosimilar Specialist (BCBBS) is taught the history of biologics, the regulatory affairs and economic considerations, and their national/international use across the world. They are experts with strong clinical knowledge of the products for development and discussions with healthcare professionals, regulatory knowledge to help the products meet FDA guidelines and streamline approvals, and economic knowledge for reimbursements and place in the market. All of these factors ease the process for a pharmaceutical company to start adopting biosimilars into their product lineup. [5]
Conclusion
In the last 5 years, biosimilars have grown slowly but steadily in their ability to bridge the affordability gap that biologics created. As they are a relatively new addition to the healthcare system and drug markets, there’s still more room for them to expand in the market through pharma companies adopting them or new market entries using different business strategies for their competitive edge. With their current rate of growth, and a strong future projected for them in the coming years, more biosimilars will make their way into the international markets, and patient accessibility to biologic treatments should be less of an issue. Pharma companies would do themselves a great benefit by adding biosimilars to their research and development, as it could expand their market presence and give them new avenues to innovate modern healthcare in the near future. [4]
References:
1. Biologic Meds. The Real Cost of Biologic Drugs. Nov. 2024 https://biologicmeds.org/biologic-basics/the-real-cost-of-biologic-drugs/
2. American Cancer Society. What are Biosimilar Drugs?. Apr. 2022
3. Biologics HQ. Samsung Bioepis Biosimilar Market Dynamics 7th Edition, Q4 2024. Sept. 2024
https://biologicshq.com/wp-content/uploads/2024/12/SB-Biosimilar-Market-Report-Q4-2024.pdf
4. Alira Health. Global Biosimilars Landscape in 2024: Trends, Challenges, and Opportunities. Accessed on Jan. 19, 2025
5. ACMA. The Board Certified Biologics and Biosimilars Specialist Program (BCBBS®). 2025.
