Significant factors involved in the growth and potential impact of biosimilars include budgetary pressures to reduce healthcare expenditures, patent expiries of blockbuster drugs, growing demand for low-cost alternatives, an increasingly aging population, government initiatives and rising incidences of various diseases.
Biosimilars play the same role as generic medicines—providing competition after a drug loses its patent protection. But while traditional medications can be replicated verbatim, more modern biological therapies are harder to produce. Biosimilars is the term used for less expensive drugs that are a close match to a patented original and provide the same therapeutic effect.
Because biotech drugs are made from living cells, it is impossible to manufacture exact copies as with simple medicines, so regulators have conceptualized the notion of approving products similar enough to do the job. Andrew Baum, an analyst at Citigroup, has predicted biosimilars will result in at least $110 billion of value being transferred from innovator companies to biosimilar producers between 2015 and 2025, generating $50 billion in savings for health systems. Globally, there are 280 biosimilars in the pipeline, and related clinical trials are increasing at a rate of 20% annually. Oncology is the largest and fastest growing segment of the space, accounting for 25% of the global biosimilar market.
Five years after enactment of the Biologics Price Competition and Innovation Act, we now are witnessing activity around biosimilars. According to the Generic Pharmaceutical Association 2014 Annual Report, the FDA revealed in late summer it had held dozens of meetings with biosimilar manufacturers to discuss the processes leading up to the filing of at least 14 different brand biologic products, and in 2014 the FDA accepted three biosimilar applications. And the Congressional Affordable Medicines Caucus sponsored a briefing on biosimilars with a panel of experts comprised of key strategic allies. “Add to these events the release of a new industry guidance on biosimilarity and another on exclusivity, and the picture is clear: the U.S. biosimilars market has taken flight. Yet, while we know the future for biosimilars is as bright as it was for small-molecule drugs 30 years ago, there remain challenges to achieving the full potential of better health and increased savings.”
So what does this mean for the clinical research site landscape? All indicators would point to this as a new avenue for business development and another pipeline for sites to approach proactively.
While there are restrictions in the U.S. biosimilars market due to a stringent regulatory environment, activity in the space is expected as early as the second quarter of 2015. Also, the paradigm shift to expand biologics and increase patient access to high quality biologics is attractive. It also is important to remember biosimilars are not “new” drugs.
CROs such as Quintiles offer the investigator knowledge and opportunities through its biosimilars knowledge connect resource. Quintiles discusses the potential with its site partners to educate and engage investigators in biosimilars research. Its web site asks investigators their experience in this field of research and/or their desire to become engaged. PPD also promotes a biosimilar clinical trial network, as does PRA Health Sciences and Parexel. As a first step, sites should become better educated in this area, and then reach out through existing avenues and resources to move ahead in this emerging, but steadily growing, new field of clinical research.
Also key to consider: According to the National Review of Drug Discovery, seven out of 10 of the world’s top-selling medicines are biologics, and they are forecasted to account for 70% of NDAs by 2025. It will be critical for any site hoping to get into the game to recognize and understand the unique differences and challenges involved in developing these products.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to email@example.com.
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