Over the next few years, patent protection over many expensive biological medicines will expire. The pharmaceutical industry calls this the patent cliff. For patients, Velizar Kirilov says, this could open the door to new competition and lower prices. His research asks whether it could also open another door through which new pharmaceutical innovators enter the market.
Velizar, a doctoral researcher at the EUI Department of Law, studies competition and innovation in the pharmaceutical industry. In a recent paper on biosimilar competition, he argues that biosimilars should not be understood only as cheaper alternatives to existing biologic medicines. The paper won first place for Best Junior Paper at the 2024 Florence Conference on IP, Competition and Innovation and the 2026 Antitrust Writing Award, organised by Concurrences and The George Washington University, in the Students Awards category.
In the paper, Velizar identifies two ways in which biosimilars may create innovation value. First, they can improve existing treatments by changing how a medicine is administered or produced. Second, he argues, companies that develop biosimilars may build the scientific and industrial capabilities needed to create originator biologic medicines in the future.
“My research was inspired by the observation that biosimilar entry may deliver more than just lower-priced alternatives,” he says. “Some of the cases I look at show that biosimilars may offer advances in drug delivery or rely on improved manufacturing processes compared with the original biologic. These improvements can benefit patients by making treatment more convenient and easier to follow.”
To explain why this matters, Velizar begins with the difference between small-molecule medicines and biologics.
Small-molecule medicines, he explains, are synthesised through chemical processes. They include familiar drugs such as aspirin and paracetamol. When patent protection on this kind of medicine expires, other firms can make generic versions at low cost. As Velizar puts it, these firms do not need to repeat the original research and development because the drug and the main technical information are already in the public domain.
Biologics are different. Velizar describes them as large, complex molecules, usually therapeutic proteins, produced in or extracted from living organisms such as genetically modified cells. They are used to treat serious and complex conditions, including in oncology and immunology. He notes that biologics are highly sensitive to how they are made because even small changes in the manufacturing process can affect their structure and function.
Biosimilars are medicines developed to compete with biologics once their period of exclusivity ends. Velizar says they play a similar market role to generics, because they enter after legal protection expires and compete with an existing medicine. The science, however, is different. According to his explanation, the manufacturing process of the original biologic is normally protected as a trade secret. A biosimilar developer therefore has to create an alternative process, including a new cell line.
“Developing a biosimilar is much more complicated, uncertain, and costly than making a generic,” Velizar says. “It requires biotech know-how, specialised facilities, and potentially clinical trials before the medicine can receive marketing authorisation.”
Velizar also points to the European Commission’s view that biosimilar development is closer to the research and development behind an original drug than to that behind a generic. For him, this is where the legal and economic questions begin.
“If developing a biosimilar already requires substantial scientific work, then we need to ask what kind of innovation biosimilars can deliver,” he says. “And if companies try to block or delay biosimilar competition, we need to ask what competition law can do about it.”
His research answers the first question by identifying cases where biosimilars improved how medicines are delivered or made. One example concerns a treatment for autoimmune disease. The original medicine is delivered as a hospital infusion, while the biosimilar version can be injected subcutaneously by patients themselves at home. In another case, he points to the cancer drug Tecentriq. Anticipating the loss of exclusivity, its manufacturer, Roche, developed a new version that reduced treatment from an infusion lasting up to an hour to an injection of about seven minutes.
For Velizar, these examples show that biosimilar competition can matter for patients beyond the price of treatment. It can make medicines easier to take, reduce the time patients spend in clinical settings, and encourage originator companies to improve their own products before competition arrives. These benefits are exactly why competition law needs a workable framework for judging strategies that could hold pipeline biosimilars back.
His second finding concerns the companies behind biosimilars. Velizar argues that biosimilar development requires a level of scientific capability that is closer to original biologic innovation than to traditional generic production. A company that masters this work may be well placed to develop new biologic medicines later.
“Companies that develop biosimilars need capabilities that are closer to those of original drug developers than to those of traditional generic producers,” he says. “That makes a biosimilar developer more likely to become an original biologic innovator over time than a generic firm is to become a small-molecule innovator.”
This means, in Velizar’s argument, that biosimilar competition may create value even when a specific biosimilar does not introduce a new delivery method or manufacturing improvement. The process can still expand the group of firms able to innovate in the biopharmaceutical sector.
This is where his broader doctoral research enters the story. Velizar’s thesis examines competition through innovation in pharmaceuticals and the race between companies to develop new or improved medicines that can treat diseases more effectively.
“Drug innovation is both collaborative and competitive,” he says. “Companies often work together to deal with uncertainty, regulatory complexity, and high costs. At the same time, they compete intensely in many therapeutic areas.”
Velizar’s thesis focuses on the legal problems that arise when one company may use patents, trade secrets, or other exclusive rights to keep an innovating rival out of the market. These rights are central to pharmaceutical research, because they allow companies to protect their investment and the knowledge behind a medicine. But his research examines the circumstances in which their use may go too far.
“The most dangerous type of exclusion is one that risks delaying or preventing an innovative medicine from reaching the market,” he says. “My thesis asks when the exclusion of an innovating rival violates competition rules.”
In the context of biosimilars, Velizar argues, that question becomes especially important. If biosimilar companies can improve treatments and help build the future base of pharmaceutical innovation, delaying their entry may harm more than price competition.
He is careful not to present patents, trade secrets, or regulatory exclusivities as problems in themselves. In his account, they play a very important role in a field where research is expensive and uncertain. Without them, companies may have weaker incentives to invest in risky drug development.
“Roughly 90% of drug projects fail, and only about 10% reach the market,” he says. “It can take a decade or more to bring an innovative medicine to patients.”
For this reason, Velizar argues that competition law enforcement must be carefully targeted. If it limits intellectual property rights too strongly, it can weaken the incentives that support pharmaceutical research. If it allows those rights to be used too broadly, it can protect one company in a way that blocks valuable innovation by another.
For Velizar, the role of competition law is to preserve this balance. It should protect the rights that make innovation possible, while responding when those rights are abused so as to exclude capable innovators from the research and development race.
“Patents and trade secrets are meant to promote innovation,” he says. “When they are used to block rival innovation, the question is whether this should be treated as a competition-law offence.”
Velizar’s route to this research began in Sofia, Bulgaria, where he studied law. He knew he wanted to pursue a PhD, but the field was not obvious at first. Alongside law, he was interested in biomedical science, architecture, and history. Competition law entered through moot court competitions, where students argue fictional legal cases before panels of judges.
“I participated in three moot court competitions, and two of them involved competition law,” he recalls. “That sparked my interest in the field. After the last competition, I had no doubts that I wanted to focus my PhD on competition law.”
Pharmaceuticals brought together his legal and biomedical interests. “I wanted to work on a subject with a huge social impact,” he says. “There are few industries as critical to society as pharmaceuticals.”
At the EUI, Velizar says he found room to pursue a subject that remains rare at the Institute. When he arrived four years ago, he says, no one at the EUI was working on the intersection of competition law and pharmaceuticals. “As far as I am aware, I am currently the only researcher at the Institute working on pharmaceutical innovation,” he adds.
Velizar will defend his thesis in Autumn 2026. By then, the patent cliff will be closer. As protection expires on high-value biologic medicines, he expects more companies to try to develop biosimilars. His research argues that this competition should not be delayed by anti-competitive strategies, because biosimilars may deliver innovation value as well as lower prices.
“It is important that research competition and market competition work smoothly,” he says.
Because, after all, there is much more at stake. When he talks about why the work matters, he returns to the people waiting at the end of it. “For many diseases there is still no cure, and treating others comes at a real cost to patients,” he says. “Getting the competition and intellectual property rules right is part of what decides whether that changes.”
Velizar Kirilov is a PhD researcher at the EUI Department of Law. His thesis ‘Rivalry through Innovation: Strategic Blocking, Antitrust and Pharmaceutical Progress’ is supervised by Nicolas Petit. His research has been published in the International Review of Intellectual Property and Competition Law (IIC) and the European Competition Law Review.
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