Juliana Reed, MS: The Future Evolution of Biosimilar Development in the US

The recent publication of a peer-reviewed report by the Biosimilars Forum delved into the future trajectory of biosimilar development and its practical applications. In the first part of an interview with HCPLive Rheumatology, Juliana Reed, MS, executive director of the Biosimilars Forum, explains her team’s motivation to explore this topic, as well as the challenges impacting the development and implementation of biosimilars in the US market.

“It is crucial to recognize the scientific minds behind this paper,” Reed explained. “These distinguished scientists collectively boast over 15 years of experience in biosimilar development, spanning across numerous biosimilars and countries.”

Based on experience and backed by scientific data, the paper emphasized the need for the evolution of biosimilar development. It signifies a paradigm shift, inspired by collected experience and the growing scientific foundation, urging a reevaluation of initial principles set forth in biosimilar development over a decade ago.

When considering the barriers impacting the advancement and integration of biosimilars in the US market, Reed noted a few pressing challenges come to the forefront. Chief among them is the imperative for streamlining development.

“As the members of the Biosimilars Forum invest approximately 9 years and close to $300 million per biosimilar, there exists a substantial disconnect between the developmental requirements established at the outset and the current scientific knowledge,” Reed stated.

This extended developmental timeline unsurprisingly escalates costs. Further, developers must carefully gauge market dynamics, anticipating the landscape they'll enter years down the line. This involves assessing the potential market size and demand to ensure an adequate return on investment.

In response to this, the Biosimilars Forum underscores 2 pivotal strategies. First, Reed encouraged streamlining development processes to align with contemporary science and experience to expedite the availability of biosimilars. Second, facilitating market access by encouraging payers and pharmacy benefit managers (PBMs) to embrace pre-market competition and make room for biosimilars. These approaches can simultaneously help unlock the potential of biosimilars and ensure their meaningful impact on healthcare access and affordability.

This transcript was edited for clarity.