Creating a Protein C Biobetter

Yesterday, Biopharmaceutical Development and Production Week speaker Dr. Michiel Ultee shared with us the different between a biosimilar and a biobetter.  This March, he will be addressing how to develop and manufacture an biobetter therapeutic.

Today, he takes an in-depth look at the biobetter he'll be presenting about:

It’s a version of Protein C, an analogue that has some amino acid changes to change the property very slightly, but significantly. Protein C is a protease that was initially marketed by Eli Lilly under the name “Xigris”. It was taken off the market a couple of years ago because of one particular side effect that was difficult – that was induced bleeding in some patients. That’s because it had an efficacy that would inhibit coagulation. It had other properties that were desirable, but that was one that caused some bleeding episodes in some patients being treated for medical conditions such as stroke.

ZZ Biotech, the company that Gallus has worked with on this project, developed a new form that was re-engineered where three amino acids have been changed so that this former Protein C no longer has the ability to inhibit blood coagulation. Therefore, it does not affect bleeding that was seen before. But it retains the cytoprotective qualities of the Protein C, allowing it to be an effective therapy for stroke victims and other disease states.

So, it’s really a biobetter because it’s an improved or second generation version of the first drug, but based on the same general protein, in this case Protein C – that enzyme.

Listen to Dr. Ultee's podcast and other insights from the speakers of BDP Week here.

Dr. Ultee will be presenting the case study A New Biobetter Therapeutic – Development and Manufacturing: A Collaboration Case Study with Kent E. Pryor, Ph.D., Chief Operating Officer, ZZ Biotech at BDP Week.  For more information on this session and the rest of the program, download the agenda.  If you'd like Mike this March 24-27, 2014 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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A biobetter therapeutic versus a biosimilar

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.

Today, he answers the question:
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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A Future for Biosimilars and Biobetters

With growing concern for rising healthcare cost comes a growing demand for more affordable drugs, and a market for developing them. Biobetters and biosimilars are gaining the attention of both small and large pharma companies as an area of opportunity to deliver more cost-effective treatments. As the patents for many originator pharmaceuticals are approaching expiry, now, more than ever, biosimilars are becoming an opportunity for profit growth.

Many companies are already planning for the future of biosimilars and biobetters, whether that be in stocks, research and development for new drugs, or international expansion – biosimilars will become an intricate part of our healthcare system, similar to their role in the EU.

So will pharmaceutical companies choose to develop biosimilars or biobetters? Furthermore, how does one even define a biobetter, seeing as there is no legal or regulatory definition currently in place? Outsourcing-pharma.com states, “A biobetter improves on the original biologic by, for example, reducing the side-effect profile.” The site also discusses how biobetters will produce a need for clinical trials, which opens new business opportunities for CROs.

The Third Annual Business of Biosimilars and Biobetters event provides you with the opportunity to hear industry experts share the development and commercialization strategies that matter most.

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