Leading up to Biopharmaceutical Development and Process Week, we're going to be sharing some insights from the speakers of the event. Today, we start with Michiel E. Ultee, Ph.D., Chief Scientific Officer, Gallus Biopharmaceuticals, LLC.First, what is meant by a “biobetter therapeutic” and how do you compare it to biosimilars?
Well, let me start with biosimilars. Biosimilars are essentially generic versions of complex biological drugs. These are typically large molecules that are proteins and they have a lot of complexities in their structure. Because of that complexity and their size – typically a thousand times larger than small molecule drugs – these types of protein drugs cannot be exactly copied. A very similar version can be created and that’s what a biosimilar is.
A biobetter, in contrast, is an improved version based on the same properties of the original innovator drug, but it has some changes to its structure or its sequence that give it some better, more desirable qualities. For example, longer half life in the patient, fewer side effects, more efficacy, lower dosing. These things are all improvements that a second generation therapeutic brings to the table. Biobetter – sometimes called biosuperior – is the kind of product that I’ll be speaking about during my presentation.
Download Dr. Ultee's full podcast - and others from the speakers of BDP Week 2014 - here.
Dr. Ultee will be joined by Kent E. Pryor, Ph.D., Chief Operating Officer, ZZ Biotech to present A New Biobetter Therapeutic – Development and Manufacturing: A Collaboration Case Study. For more information on this session and the rest of the program, download the agenda here. If you'd like to join us at Biopharmaceutical Development and Process Week this March 24-27 in San Diego, as a reader of this blog when you register to join us and mention code BDP14BLOG, you'll save 20% off the standard rate!
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