Biosimilars and Future Biotherapeutics

Biobetters: The Next Generation of Biologics

Biobetters: The Next Generation of Biologics will delve into the emerging class of biologic drugs known as biobetters, which are engineered to surpass their reference biologics in terms of efficacy, safety, pharmacokinetics, or convenience. While biosimilars are developed to closely mimic the original biologics without clinically meaningful differences, biobetters go a step further by enhancing therapeutic performance through strategic modifications. As the biologics market continues to evolve, biobetters represent a rapidly growing opportunity for innovation in biologic therapy—offering significant clinical and commercial potential. These advanced modifications can result in reduced dosing frequency, improved patient adherence, and potentially superior therapeutic outcomes compared to first-generation biologics. Biobetters are increasingly being positioned as a viable next step in therapeutic evolution, not only to improve clinical benefits but also to extend product lifecycles and differentiate in a competitive market.Real-world examples of successful biobetters—such as dulaglutide (a biobetter of GLP-1 receptor agonists) and darbepoetin alfa (a modified erythropoiesis-stimulating agent)—will be discussed to illustrate their clinical and market advantages. Attendees will gain insights into the regulatory landscape surrounding biobetters, which typically follow the new biologic license application (BLA) or marketing authorization pathways rather than the abbreviated biosimilar approval process, due to their enhanced properties.