<p>The upcoming biopharmaceutical patent cliff is expected to set the stage for a large-scale market entry with biosimilars over the next decade. Unlike generic producers, their developers may be incentivized to compete on more than just price. The technological and commercial peculiarities of biosimilars suggest that they can be a source of innovation, stemming from advances in drug delivery and manufacturing processes. Although these advances fit the definition of incremental innovation, they may produce disruptive effects in niche market segments, thus blurring the line between incremental and disruptive innovation. In addition, the freedom to operate in biosimilar R&amp;D is a key condition enabling manufacturers of biosimilars to potentially expand their business models into the originator segment of the industry and puts originator producers under pressure to innovate preemptively. These innovation-related benefits highlight the importance of identifying a workable antitrust framework for assessing the effects of business strategies that may interfere with pipeline biosimilars. To that end, the article proposes applying the concept of potential competition in existing markets – previously applied to small-molecule markets – to the biopharmaceutical segment. It then discusses several open questions on this adaptation. These include, in particular, the extent to which small market size and regulatory exclusivities may rule out a competitive relationship between incumbents and biosimilar developers; the timeframe for assessing potential biosimilar competition; the features at company level that indicate the capability for a successful biosimilar entry; and the relevant market in which an innovative biosimilar would compete upon commercialization.</p>