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Biosimilars – Central and Eastern Europe perspective

Date: 14.5.2013 

It is kind of truism to say that biotechnological products are the future of medicine. Especially, if their natural property to be recognized by human body as a natural and self-produced protein combating with particular disease is taken into consideration. Biosimilar market is estimated to be worth USD 2-3 bln by 2015, and up to USD 20 bn by 2020. Is it chance for small and medium companies from Central and Eastern Europe (CEE) to have shares in this market?

Biosimilars has potential to become the most desirable medical products  of the nearest future and will revolutionize pharmaceutical market. Potentially, this market could be the single fastest-growing biologics sector in the next five years. Only until 2020 biological drugs with estimated  total sales value over USD 100 bn will be sold?. In global perspective many experts expects already now the revolution, not only in a division of  profits, but also in a map of global Big Pharma producers. In many cases small and medium companies, e.g. from the region of Central and Eastern Europe which during last years have to endure waiting for liberation of market, now are preparing for launching their products into chosen markets. Nonetheless, there are still barriers which are able to retard fast growth in biosimilars production.

Patent protection period of many biological is going to expire in 2015 and does not constitute obstacles. But the problem of complicated and demanding registration procedures will affect adversely, especially in the countries of the European Union. Only inconsiderable number of pharmaceutical companies was successful in this process. Sandoz is pioneer and leader in this competition. In the EU company has finished 3 registration procedures. In 2006, Sandoz launched recombinant human growth hormone somatropin, followed by recombinant human erythropoietin in 2007 and GSCF in 2009.  Swiss company is the only company which registered 3 biosimilar pharmaceuticals so far(?).

Such complicated procedures are effect of maladjustment of law to different character of biosimilar drugs. Uncontrollable process of adding to free hydroxyl groups additional substances, such as carbohydrates and other hydrocarbons, after RNA translation was not predicted by legislation and now extend registration period. Additionally, R&D and production process is much more expensive, in contrast to generics, and necessitates long-term investments.

It seems that such barriers make registration unreachable for small and middle companies of Life Science sector in CEE area. But it’s erroneous notion and Mabion Inc. proves that shares in biosimilars market are available not only for big pharma concerns. Polish company is at the end of the registration process and in the forthcoming future shall be victorious.

- The problem of registration of biosimilar discourages many companies or even makes it impossible for them – said Sławomir Jaros, Ph. D. vice president and manager of R&D Centre in Mabion. But it is really possible and Mabion is evidence for it. Now, when Mabion is so advanced in process of development of medicament, we would like to share experience with another companies. We are convinced, it is future of pharma market and it’s worth to debate already about.

All questions connected with complexicity of biosimilars will be discussed during panel session which will take place in Budapest on 22-23rd May 2013 pending BioForum 2013, one of the largest biotechnological  and biobusiness meetings in CEE area. The panel will consist of three parts, which will raise general aspects of biosimilars in this region of Europe. Participants are going to find out a real value of CEE market of biosimilars and perspectives of its development until 2020. They will have chance to debate advantages and disadvantages of investment in biosimilars and swap their experience.  Sławomir Jaros from Mabion will also point out the most important elements of strategy, which enabled company success in consecutive steps of biosimilar registration in the Mabion case study.

Author: Tomasz Jachimek, PR Coordinator 

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Bioforum 2013 is the 12th edition of the event aiming to create an effective market for biotechnology services and R&D partnerships within the Central and Eastern Europe region. Since 2002 we try to offer the best conditions for companies from CEE region to meet, discuss and find partners for realization their plan for development and progress. During the BioForum event, companies are able to communicate with investors and scientists from the CEE region, where everyone can offer equal terms for partnership. So far, the established partnerships have quickly translated into economic benefits.

The mission of BioForum is to create optimal conditions for the development of innovative companies in the CEE bioindustry. Growth of innovative companies will allow for the retention of our biggest resource – the talented and skilled graduates of the region’s academia. We will be able to benefit this talent in the best way by creating an ample and adequate labour market.

For more information please visit: www.cebioforum.pl




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