Introduction
Biosimilars, which are highly similar versions of biologic drugs, have the potential to significantly reduce healthcare costs by offering cheaper alternatives to expensive biologics. However, the journey to market for biosimilars is often fraught with legal and regulatory challenges, particularly those related to patents. This article delves into the impact of patents on biosimilar pricing, exploring the complexities and potential solutions.
The Role of Patents in Biologic Drugs
Biologic drugs are complex molecules derived from living organisms, making them more difficult and costly to develop than traditional small-molecule drugs. Patents play a crucial role in protecting the intellectual property of biologic drug manufacturers, allowing them to recoup their investment in research and development.
The Biologics Price Competition and Innovation Act (BPCIA)
The BPCIA, enacted in 2010, aimed to streamline the approval process for biosimilars, similar to the Hatch-Waxman Act for generic drugs. However, the BPCIA’s effectiveness has been hampered by patent litigation and the “patent thicket” created by originator manufacturers to delay biosimilar entry.
Types of Patents Impacting Biosimilar Market Launch
While manufacturing patents are commonly associated with biosimilar delays, research suggests that other types of patents, such as those related to active pharmaceutical ingredients (API), treatment methods, and composition of matter, have a more significant impact on market launch delays.
The Impact of Patent Litigation
Patent litigation is a significant barrier to biosimilar entry. Many biosimilar manufacturers choose not to engage in the complex litigation process established by the BPCIA, leading to settlement agreements that delay market entry. For example, biosimilars referencing Humira (adalimumab), Stelara (ustekinumab), and Enbrel (etanercept) have faced substantial launch delays due to patent litigation.
The “Patent Thicket” Phenomenon
The “patent thicket” refers to the extensive portfolio of patents surrounding a biologic drug, designed to protect the originator’s market share. This thicket can include secondary patents filed after the approval of the originator drug, which can significantly delay biosimilar entry.
Regulatory Barriers
Regulatory barriers, such as pre-approval testing requirements, also contribute to the slow growth of the biosimilar market. These requirements can be time-consuming and costly, further delaying market entry.
Economic Impact of Biosimilars
Despite the challenges, biosimilars have the potential to offer substantial savings. Studies have shown that biologics facing biosimilar competition may experience significant price decreases, potentially saving payers, patients, and society billions of dollars.
Case Study: Adalimumab
Adalimumab, a biologic used to treat rheumatoid arthritis, is a prime example. Following the entry of biosimilars, the projected share of total expenditures on adalimumab decreased significantly, leading to increased market share for other treatments like Janus kinase inhibitors.
Industry Expert Insights
“Biosimilar entry is estimated to depress the price of the relevant biologic by only about 4% to 10% per biosimilar entrant. This raises an important question—what is the length of time of the current, actual originator monopolies, and are they striking the right balance between incentivizing innovation and public benefit?” – Researchers from Value in Health.
Potential Solutions
Several potential solutions have been proposed to address the patent-related barriers:
- Legislative Reforms: The Affordable Prescriptions for Patients Act aims to limit the number of patents that can be asserted in infringement proceedings, potentially reducing delays.
- Increased Examiner Time: Giving patent examiners more time to scrutinize applications could reduce the issuance of invalid secondary patents.
- Collaboration Between FDA and USPTO: Sharing chemistry, manufacturing, and control information between the FDA and USPTO could help determine if manufacturing methods claimed in patent applications are being used by originator manufacturers, thereby reducing patent disputes.
Conclusion
The impact of patents on biosimilar pricing is multifaceted and complex. While patents are essential for protecting innovation, they can also create significant barriers to market entry for biosimilars. Addressing these challenges through legislative reforms, regulatory adjustments, and increased collaboration between regulatory bodies can help ensure timely access to more affordable biologic therapies.
FAQs
- What is the Biologics Price Competition and Innovation Act (BPCIA)?
The BPCIA is a legislation enacted in 2010 to streamline the approval process for biosimilars, similar to the Hatch-Waxman Act for generic drugs. - What is the “patent thicket” phenomenon?
The “patent thicket” refers to the extensive portfolio of patents surrounding a biologic drug, designed to protect the originator’s market share and delay biosimilar entry. - How do biosimilars affect the prices of biologic drugs?
Biosimilars can lead to significant price decreases for biologic drugs, potentially offering substantial savings to payers, patients, and society. - What are the main types of patents impacting biosimilar market launch delays?
While manufacturing patents are commonly associated with delays, other types such as API, treatment methods, and composition of matter patents have a more significant impact. - What are some proposed solutions to address patent-related barriers for biosimilars?
Proposed solutions include legislative reforms, increased examiner time to scrutinize patent applications, and collaboration between the FDA and USPTO to reduce patent disputes.
References
- Estimating the impact of biosimilar entry on prices and expenditures. Journal of Pharmaceutical Policy and Practice. 2022. DOI: 10.1080/13696998.2022.2113252.
- The Characteristics of Patents Impacting Availability of Biosimilars. Nature Biotechnology. 2022.
- Biosimilars: Patent challenges and competitive effects. Morgan Lewis. 2014.
- What Types of Patents Are to Blame for Biosimilar Market Delays?. Value in Health. 2024. DOI: 10.1016/j.jval.2023.12.005.