How Timing Shapes Biosimilar Success: Insights from US Market Data
A recent study published in Value in Health sheds light on the competitive dynamics of biosimilar drugs in the US, specifically examining whether first-mover advantages resemble those seen in generic drug markets. Generics are known to gain substantial traction early, often capturing 80% more market share than second entrants. For biosimilars, however, the advantage appears to be more modest yet still significant. The research projected that first movers in the biosimilar market achieve, on average, 27% higher sales than second entrants in the long run, signaling that while the edge may be smaller than in generic contexts, it is nevertheless impactful.
To reach these findings, the study analyzed data from the IQVIA National Sales Perspective, covering monthly pharmaceutical sales from 2015 to 2023 across 6 major biosimilar markets: bevacizumab, filgrastim, infliximab, pegfilgrastim, rituximab, and trastuzumab. Using a combination of exponential decay and logistic growth models, the researchers projected long-run steady-state market shares for both first movers and later entrants. The results showed that in 4 out of the 6 markets, the first-mover biosimilar consistently outperformed all later competitors, securing a long-run share that was 8.9 to 12 percentage points higher than the second entrant.
Although these percentages may appear modest, the financial implications are substantial. Given the immense size of biologic markets, each percentage point of market share represents roughly $5 million in annual sales. This means that a first-mover advantage of nearly 9 to 12 percentage points can translate into tens of millions of dollars in sustained revenue. Such advantages help explain why some companies are willing to accept the risks of early entry, sometimes even before fully resolving complex patent disputes, in order to establish a foothold in highly lucrative therapeutic areas.
The study ultimately highlights how first-mover advantages in biosimilars, though less pronounced than in generic drug markets, still play a decisive role in shaping competition and strategy. For developers, the opportunity to secure a durable lead can strongly influence decisions about market entry timing and investment in product development. At the broader market level, these dynamics affect how many competitors choose to enter, how quickly prices decline, and ultimately how accessible these therapies become to patients. In this way, the findings underscore the far-reaching consequences of timing and strategy in biosimilar development.
Reference
McGeeney JD, Sertkaya A, McCormick SA, et al. Measuring the First Mover Advantage in US Biosimilar Markets. Value Health. Published online July 21, 2025. doi:10.1016/j.jval.2025.07.011
