SOURCE: INC Research

INC Research

February 24, 2011 07:06 ET

INC Research Releases Paper on Clinical Development for Biosimilars in Europe and United States

Senior VP of Endocrine and Cardiovascular Covers Regulatory Requirements and Risk Management for Developing Biosimilars in Europe and US

RALEIGH, NC--(Marketwire - February 24, 2011) - INC Research, LLC., a therapeutically focused contract research organization (CRO) with a trusted process for delivering reliable results, has released its latest inDepth paper titled, "Development of Biosimilars, A Clinical Perspective," which gives an overview of the philosophy behind the clinical and regulatory requirements for the development of biosimilars.

Dr. Hans-Peter Guler, who has recently been promoted to senior vice president, Clinical Development of Endocrine and Cardiovascular at INC Research, provides historic and background information on originator proteins and biosimilars, or follow-on biologics, and explains some of the hallmarks of the development of biosimilars given their complex, high molecular structure, synthesis, purification and characterization.

Biosimilars are expected to improve accessibility to the protein drugs as the costly originator compounds come off patent. Currently, the worldwide biosimilar market is less than $100 million, but by 2014 it is estimated to grow to approximately $2 billion in seven major markets, according to a Datamonitor report.

Dr. Guler uses approved biosimilars in the European Union (EU) to demonstrate the clinical requirements for biosimilar drug development, including epoetin (erythropoietin), somatotropin (growth hormone, GH), and filgrastim (G-CSF). He shares his thoughts on the expected cost reductions with biosimilars particularly compared with small molecule drugs.

inDepth is a series of papers from therapeutic and operational thought leaders at INC Research. They provide a closer and more comprehensive look at current clinical development topics that have an impact on clinical trials outsourcing and global drug development.

Download a copy of "Development of Biosimilars, A Clinical Perspective" from the company's Resource Library.

About the Author
Hans-Peter Guler, M.D., senior vice president, Clinical Development at INC Research, has more than 20 years of experience in the clinical research industry. Prior to joining the global CRO, Dr. Guler served as chief medical officer/VP Clinical Development at Phenomix for six years. Prior to that, he held positions of increasing responsibility with Regeneron Pharmaceuticals, Inc., Chiron Corp. and Ciba-Geigy Corp. His work in clinical research included studies at all stages from first-in-man to large registration trials. Indications studied included diabetes mellitus, obesity, rheumatoid arthritis, hepatitis C, asthma, sepsis, cardiovascular disease, and renal failure. Prior to accepting his first job in industry, he conducted some of the early studies with recombinant insulin-like growth factor I in academia. He is an author of more than 30 peer reviewed articles. Dr. Guler trained in Switzerland and received his M.D. from the University of Zurich.

About INC Research, LLC.
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit or follow us at @inc_research.

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