How to achieve your biosimilar milestones on time
In the next decade, many blockbuster biologics will lose their patent exclusivity, creating a new wave of opportunity for biosimilar drug developers. To secure a corner of their intended market, manufacturers must build a robust strategy to biosimilar development and manufacturing that considers not only how best to reach their target patients, but how to meet the most effective development timeline. Though biosimilar developers can learn from the paths already forged by more experienced companies, the biosimilar space comes with its own unique challenges. These include but are not limited to selecting the ideal market for product launch, manufacturing a biosimilar with no clinically meaningful differences from its reference product, and obtaining regulatory approval amid rapidly evolving guidance.
As you plot your path forward, consider the key milestones of biosimilar success—reference product selection, analytical characterization, clinical trials, regulatory approval, and commercial launch―and how to leverage strategic financial, regulatory, clinical, and manufacturing approaches to reach these milestones efficiently.
1. Select the biosimilar market best positioned for opportunity
Ideally, biosimilars can be manufactured at significantly lower costs—15 to 20 times less—than their reference products, thanks to the fact that the originator molecule has already obtained regulatory approval and proven their safety and efficacy (1). That said, biosimilars still require a steep financial investment despite an uncertain trajectory. Because it is unlikely these drugs will benefit from the same level of market uptake as their innovator counterparts, biosimilar developers will need to strategically select their target molecule and market based on expected revenues and ROI (2).
To build a well-informed approach to commercialization, conduct a thorough analysis of potential markets that considers patient need, regulatory approvability, and the probability for market penetration (3). With this data at hand, you will be better positioned to not only select a market that demonstrates a significant opportunity for profitability but to design an effective biosimilar strategy for said market. Leveraging market-specific strategies is critical to edging out biosimilar competitors that also intend to launch in your market of choice. Therefore, stake your foothold in the market by engaging with key stakeholders—patients, physicians, and payers—as early as possible (4).
Engaging with payers, i.e., insurance companies, early will help your team procure favorable coverage and reimbursement policies for your product; as a result, you can offer patients increased affordability and accessibility (2). To better reach physicians, consider your treatment guidelines, possible prescribing incentives, and the appeal of real-world data and experience (3). Overall, market success will require a cross-functional approach that leverages the insight of experienced medical, manufacturing, and market experts.
2. Align yourself with regulators early in your biosimilar development timeline
The pathway to regulatory success depends wholly on your market of choice. Because there is no global harmonization for biosimilar regulations, it is important to consider which regulatory authorities provide supportive pathways to biosimilar approval during your market analysis. Once you have identified a target market, strive to build a relationship with the regulatory agency that oversees it (5). Meeting with regulators as early as possible will help ensure that you capture their interest in your product sooner and avoid any missteps that could impact compliance.
Though both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have stringent requirements for regulatory approval of biosimilars, they have clearly outlined their expectations to provide ample guidance for developers. Key requirements include analytical studies to compare the biosimilar and its reference product; non-clinical studies on animals to evaluate toxicity and immunogenicity; and clinical studies that gather data on pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity (2).
For biosimilar developers considering a US market launch, the FDA offers two types of biosimilar meetings: Biosimilar Initial Advisory (BIA) and Biosimilar Biological Product Development Type 2 (BPD2). The BIA meeting is free and meant for the early stages of biosimilar development while the BPD2 meeting is not free and should be reserved for when biosimilar development has progressed further; if the FDA deems that development has progressed too far, they may convert the meeting to a BPD2, in which a sponsor would miss out on the opportunity to discuss the development direction (5). As such, companies should avoid progressing too far beyond the initial concept stages to reap the insights of a BIA meeting.
3. Consider trial design in your biosimilar manufacturing strategy
Clinical trials for biosimilar approval are required in highly regulated markets such as the European Union (EU), US, Japan, Canada, and Australia; if you are hoping to break into one of these markets, strategic trial design should be top of mind (6). With biosimilar clinical trials, your primary goal is demonstrating biosimilarity to the reference product. Key considerations for this goal include the molecular structure and mechanism of action of both the innovator and biosimilar; target indication; target patient population; safety information; and the complexity of any clinical endpoints required by regulators to establish efficacy and comparability to the innovator (3).
Beyond the technical aspects of trial design, robust patient recruitment is critical for your trial to reach its target goals within the intended timeline. One strategy for effective patient recruitment is opting to conduct your trial in a country or countries with a significant unmet need for your therapy, including countries that do not currently have access to the reference product, which will speed up recruitment of your target patient population (3).Some biosimilar developers also opt to combine Phase I and Phase III studies to save time in clinical development (4).
4. Strike the right balance while addressing biosimilar manufacturing challenges
Biosimilar manufacturers are looking to achieve speed, efficiency, and high quality across their manufacturing processes, all while ensuring consistency with the innovator molecule. As such, biosimilar developers are saddled with a unique conundrum: is it best to implement innovative technology, equipment, and analytical capabilities to increase manufacturing efficiency? Or is it best to replicate the originator’s manufacturing process to achieve maximum biosimilarity (7)? As you decide when or where optimization might fit into your process, consider the risks of amplifying quality differences, which is particularly relevant for post-translational modifications like glycosylation (5).Furthermore, improving manufacturing processes too much could lead a molecule to the designation of “biobetter”, which would result in a longer development timeline and more challenging regulatory approvals (5).
One strategy to help thread this delicate balance is opting to work with an experienced contract development and manufacturing organization (CDMO) that has previously guided innovator molecules and biosimilars through development. A knowledgeable CDMO will be able to make strategic recommendations on where to build optimization into the manufacturing process while still ensuring biosimilarity to the reference product. They will also be able to provide guidance on how to achieve regulatory compliance and clinical optimization for your target markets.
5. Plan your path to market accordingly
Ultimately, the success of your biosimilar will depend on your team’s ability to strategically select a target market and then create an effective development and manufacturing strategy to facilitate entry. It is then critical to work closely with the appropriate regulatory authority along the way to maintain continued compliance. Considering the complexity of these tasks, the growing competition as the industry approaches the impending biosimilar patent cliff, and the importance of expanding access to affordable biologics worldwide, it is vital to take strategic steps at the outset to secure your spot in this emerging landscape.
References
- Lechleider T. Biosimilars: a cure for the higher price of complex drugs? American Century Investments. https://www.americancentury.com/insights/biosimilars-cure-for-the-higher-price-of-complex-drugs/. Published March 11, 2024. Accessed January 12, 2026.
- Beelke ME. Navigating the high stakes of biosimilar development: strategic decisions, supersimilars, and regulatory hurdles. LinkedIn. https://www.linkedin.com/pulse/navigating-high-stakes-biosimilar-development-strategic-beelke-aw2je/. Published August 3, 2024. Accessed January 12, 2026.
- Dahal D, Chance K, Doyle J. An integrated approach to biosimilar development & commercialization. Quintiles. 2014. Accessed January 12, 2026. https://www.iqvia.com/-/media/library/white-papers/integrated-approach-to-biosimilar-dev-and-commerc.pdf?la=en
- Carlsen J, Estdale S, Kaiser R, Donninger R, Bower J. Key considerations in biosimilars development. BioPharm International. https://www.biopharminternational.com/view/key-considerations-biosimilars-development. Published October 1, 2012. Accessed January 12, 2026.
- Kirchhoff CF, Wang XM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114(12):2696-2705. doi:10.1002/bit.26438.
- How a biosimilar is developed. Biosimilars Council. https://biosimilarscouncil.org/resource/how-a-biosimilar-is-developed/. Published October 5, 2020. Accessed January 12, 2026.
- Brorson K, Nick C. The five key decisions for every biosimilar development program. DIA Global Forum. https://globalforum.diaglobal.org/issue/october-2022/the-five-key-decisions-for-every-biosimilar-development-program/. Published October 2022. Accessed January 12, 2026.