CEE Offers an Optimized Path for Biosimilar Research Execution, says KCR

WARSAW, POLAND - Jun 12, 2014 - Warsaw - 12 June 2014 - Europe was the first region worldwide to introduce a clear regulatory pathway for biosimilar medicines. This approach resulted in the highest number of biosimilars’ approvals globally. Central and Eastern Europe (CEE) is and is predicted to remain an important area for biosimilar research and development (R&D). However, there is a growing need to educate regional regulatory bodies, as well as patients and investigators about the products potential.

“In recent years the biosimilar market has been expanding with R&D investments significantly raising. CEE enabling conduct of a full trial in a single region coupled with highly professional research services is a great area to be tapped into,” says Anna Baran, KCR, Vice President and Chief Medical Officer.

Rapid expansion of biosimilars market and pressure of health systems seeking wider adoption of biosimilars force regulatory agencies to create a favorable environment for this type of medicines.

The CEE region authorities have continuously been working on the regulatory framework to allow biosimilars enter the research stage. “Russia is still a challenge in this matter, as the country has no specific regulation pertaining to biosimilars. However, requirements for the conduct of clinical trials for biosimilar drugs are still topic of much discussion,” adds Dr. Baran.

Implementing biosimilar studies across CEE countries involves layers of complexity in following local regulatory framework development. Yet, with a service provider having an in-depth knowledge of each country the said challenge can be easily overcome. Furthermore, the regional physicians are being more and more open to the biosimilar concept and benefit from joining clinical research at relatively low complexity.

“Patients’ recruitment and retention is a significant issue in a biosimilar study. Therefore, extensive communication between a subject and an investigator is crucial. Implementing new solutions such as Risk Based Monitoring (RBM) and integration between processes and technology will play a major role in achieving efficiency in conducting the trial,” notes Mike Jagielski, KCR, CEO.

The CEE region holds an immense potential for conducting biosimilars studies. Regardless regulatory obstacles and market stakeholders in need of proper education in this area, sponsors might greatly benefit from the region capacity. Cooperation with locally experienced service provider offering efficient Data Management solutions will result in an efficient and successful endeavor.

Presentation on the “Optimized Path for Biosimilar and Generic Development in CEE” by Dr. Anna Baran was delivered during the recent BioForum 2014. If you would like to receive this presentation or learn about KCR services, please contact Joanna Lewandowska, PR & Marketing, at joanna.lewandowska@kcrcro.com. Please include your full contact details in the query.

About KCR

KCR is a European Contract Research Organization (CRO) and strategic solutions provider for companies who are looking for a reliable alternative to global CROs. Almost 300 professionals operating across 18 countries in Europe as well as the U.S. offer full service capabilities for Phase I-IV Clinical Development Projects across a wide range of therapeutic areas. KCR also operates as a Functional Service Provider with strategic and tactical solutions in Clinical Operations, Data Management and Expert Sourcing. Our service portfolio includes delivery of regional and local Post-Marketing Clinical Services according to the clients’ needs. KCR supports 12 of the Top 20 Global Pharma companies with its services on long standing global or local contracts.

For more information please visit: www.kcrcro.com.

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