Biosimilars Are No Longer Just a Big Pharma Game

The economics of biosimilar development may be approaching an important turning point. Advances in analytical science, evolving regulatory expectations, and emerging manufacturing technologies are prompting developers to reconsider how biological medicines reach the market. Pharmaceutical scientist and inventor Dr. Sarfaraz K. Niazi has spent decades arguing that scientifically justified development pathways could make biosimilars less expensive to develop and more widely available. His perspective draws on academic research, industry experience, patent innovation, and direct engagement with regulators.

Dr. Niazi’s interest in simplifying scientific problems began early. After arriving in the United States from Pakistan as a teenager to study at Washington State University, he continued his education in Chicago and became a tenured professor at the University of Illinois at Chicago at age 27. His career subsequently extended into the pharmaceutical industry, international biotechnology research, and therapeutic protein development. He has authored numerous scientific books, including the first books in the field, coining the term “biosimilars,” and hundreds of peer-reviewed papers, and built an extensive U.S. patent portfolio. He is an advisor to the USFDA and EMA, among other agencies. These experiences informed his view that innovation depends on both scientific discovery and the systems that translate discoveries into treatments for patients.

That conviction became particularly relevant as biosimilars emerged as an option for expanding access to biological medicines following the expiration of patents on reference products. Biosimilars are biological medicines demonstrated to be highly similar to an approved reference product, with no clinically meaningful differences in safety, purity, and potency. “Proving that these molecules are similar takes advanced testing. Because biological molecules are so complex, even minor shifts in manufacturing can affect how they turn out,” Dr. Niazi explains. He argues that evidence requirements should reflect each molecule’s characteristics and the scientific questions that remain to be resolved.

“A biosimilar delayed is a biosimilar denied,” Dr. Niazi emphasizes. This philosophy captures the public-health concern behind his work. Development timelines can affect when additional treatment options become available, while program costs can influence which companies are able to participate. 

“Developing a biosimilar can cost $100 million to $150 million, which makes it difficult for smaller biotechnology companies to participate,” Niazi shares. “With the right scientific and regulatory strategy, I have brought the cost down to around $15 million for certain products. This opens the door for more developers and helps make these important medicines more accessible to patients.”

Dr. Niazi has advanced this position through scientific publications, citizen petitions, and meetings with regulators and the US Senate. His advocacy has addressed reference-product selection, statistical methods for assessing analytical similarity, and the scientific value of animal toxicology studies for biosimilars. These requirements can influence the materials developers obtain, the experiments they conduct, and the time needed to complete a program.

Reference-product comparisons depend on suitable materials and a sound scientific rationale for their use. Statistical models also need to account for variability in biological products so that observed differences can be interpreted appropriately. “Science moves fast, and our standards should keep up. By using newer testing tools to update regulatory requirements, developers can target their efforts on solving genuine uncertainties rather than ticking outdated boxes,” Dr. Niazi argues.

Animal testing has also been a focus of his work. In a letter published in Science in 2022, Dr. Niazi questioned the usefulness of certain animal toxicology studies for biosimilars, noting that biological differences between animals and humans may limit the relevance of some results. Separately, the FDA Modernization Act 2.0, signed into law in 2022, removed a statutory requirement for animal testing before certain investigational drugs enter human clinical trials and supported consideration of alternative methods. The legislation does not exempt every product or study from applicable requirements, but it reflects broader interest in scientifically appropriate testing methods. Dr. Niazi’s published advocacy contributes to this wider discussion about how evidence requirements can evolve alongside scientific capabilities.

The economic implications extend beyond individual development programs. If lower costs make more biosimilar projects financially feasible, additional manufacturers may have opportunities to enter the market. Dr. Niazi says, “A wider supplier base could support greater availability and create more scope for price competition, although actual outcomes would depend on regulatory approvals, manufacturing capacity, procurement practices, reimbursement arrangements, and the number of viable suppliers.”

Dr. Niazi illustrates this affordability gap using granulocyte colony-stimulating factor (G-CSF), a biologic used to manage chemotherapy-induced neutropenia. “A ready-to-use syringe costs around $4 to manufacture, yet it carries a reported selling price of $250,” he notes. While these figures reflect a specific product rather than a universal market rate, they highlight the vast divide between manufacturing expenses and end-user costs, which are driven up by regulatory compliance, quality assurance, distribution, and commercial overhead. For patients paying out of pocket, this price gap directly dictates whether or not they can access life-saving care. The WHO has reported that the manufacturing costs for biosimilars can range between $95 and $200 per gram, when the US government is paying $3,500 per gram, equaling up to $25 million per product. He helped write the Inflation Reduction Act, which unfortunately was opposed by many biosimilar associations as well as big pharma on the basis that if the cost of biosimilars goes down, it will be less attractive to biosimilar manufacturers. 

His interest in affordability extends to manufacturing technology. Dr. Niazi has explored cell-free protein synthesis, which uses biological machinery outside intact living cells to produce proteins. For suitable molecules, this technology could reduce reliance on conventional cell-culture systems and large bioreactors. Its commercial potential will depend on production yield, product quality, scalability, and validation, making product-specific assessment essential. Nevertheless, cell-free systems offer a potential avenue for developers seeking alternative ways to manage manufacturing infrastructure and costs.

Dr. Niazi’s wider body of writing reflects an interest in the relationship between scientific knowledge and human welfare. His publications examine biological medicines, pharmaceutical manufacturing, and mRNA therapeutics, while his book The Unchosen Self considers how inherited identities influence human behavior and how greater understanding may support a more peaceful society. Although distinct in subject, these areas of work reflect his broader interest in applying knowledge to problems that affect people’s lives.

This mindset is anchored in his core belief that science should serve mankind. “Applying my passion for physics to watchmaking, I often say that every tick has value,” Dr. Niazi shares. He notes that this principle translates directly into pharmaceutical research, where meticulous evidence and efficient resource management are critical for patients awaiting life-saving treatments.

The future of biosimilars will depend on rigorous science, workable regulation, reliable manufacturing, and healthcare systems that support access. Dr. Niazi’s career, from early academic achievement and industry experience to regulatory advocacy and exploration of new production technologies, offers a perspective on how these elements might advance together. He remarks, “If development becomes more efficient while product quality and patient safety remain essential priorities, biosimilars may create opportunities for more manufacturers and expand treatment options for patients worldwide.”