Meeting: May 20-21 | In-Person

Co-sponsored with the United States Pharmacopeia (USP)!

Fourteen years after a regulatory pathway for biosimilars was established in the United States, the biosimilars landscape has transformed dramatically. These biologic products, which closely mirror original biologics, now serve as cost-effective alternatives once the original product's patent expires. To date, numerous biosimilars have been approved, covering therapeutic areas such as endocrinology, immunology, oncology, ophthalmology, and supportive care. While new biosimilars continue to be approved, the market uptake of many biosimilars has been slower than anticipated, pointing to ongoing challenges in adoption and equitable access.

In response, regulatory bodies around the world are exploring opportunities to streamline biosimilar development, to lower development costs and improve patient access. This approach leverages advances in science as well as knowledge gained over time with biosimilars including better knowledge of what attributes are most important, innovative analytical methodologies and real-world experience with these products. Taken together, this has led to a global shift in regulatory thinking.

The 2025 DIA/USP Evolution of Biosimilars Development Workshop: Evaluating What We Have Learned and Where We Are Headed, taking place May 20-21, 2025, will bring together global experts from regulatory agencies, industry, and advocacy organizations to discuss recent advances in biosimilar regulatory science and development paradigms. This two-day event will feature sessions on global regulatory convergence, innovations in analytical technologies, and critical manufacturing considerations. Through presentations, panel discussions, and workshops, attendees will engage with case studies and explore novel pathways emerging worldwide to make biosimilars more accessible and cost-effective.

The workshop will also provide valuable networking opportunities, enabling participants to collaborate and drive forward solutions for advancing the quality and reach of biosimilars globally. Post-conference communications will reinforce shared insights and support ongoing dialogue on addressing the future of biosimilars.