The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.
There are hundreds of potential biosimilar candidates that can be brought to the market readily to expand into the untapped market of biosimilars without significant patent challenges and producing significant revenue. Not least of the advantages is fulfilling the dire need for affordability. Yet, with over 100 biosimilars approved in the European Union and United States, we can see a trend that all companies are running after the market leaders like adalimumab. There is even a bigger market potential available in the forgotten molecules. Of the 83 biosimilars candidates, whose patents have expired, only 18 molecules are approved in the European Union and 11 in the United States (Figure). Antibodies lead the list of over 100 approved biosimilars. It is about time that we find the hidden biosimilar gems and expand the market of diseases treated with biosimilars.
The question arises, why are we hovering over a relatively small number of molecules approved in the European Union and the United States? In this column, I will answer this question and suggest how biosimilar developers can go against the grain. With this column, I have included patent expiration dates for molecules that are available for biosimilar development or will be (Table).
A detailed analysis of the 100 approved biosimilars in the European Union and United States reveals that there is no impossible challenge in getting a new biosimilar approved. The regulatory agencies worked with extreme sensitivity as they tried to overcome the shadow of risk cast by the originator companies—“only we know how to make these products” was a slogan that has evaporated now. The science of biosimilars is now better understood, the milestones to reach biosimilarity are evident, and the technology to produce biological drugs has lowered the cost of goods.
Still, the most significant investment in the development of biosimilars remains their testing for safety and efficacy in a clinical setting. This exercise is most demanding for oncology products, where a larger population of patients than for the originator biologic is required to prove similar efficacy and safety because it is impossible to secure a treatment-naive patient population; thus there is a very high degree of variability in their responses due to prior treatments.
So, how should a developer choose a product as a biosimilar candidate?
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.