Report from Poland

With a population of 38 million, Poland has the largest pharmaceutical market in Central and Eastern Europe (CEE). But in terms of international competiveness and exports performance, its pharmaceutical industry lags behind other smaller countries in the region, like Hungary. Now the Polish pharmaceutical industry is trying to catch up on the international stage.

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But instead of focusing on chemical-based medicines, it is concentrating on biopharmaceuticals, in particular biosimilars. Poland's government wants to establish a knowledge-based economy in the country. So it sees biotechnology, in which biopharmaceuticals is the fastest growing segment in Poland, as one way of doing this.

In academia, the country already has a number of centers of expertise in biotechnology which gives it a relatively active R&D platform in the discipline and, above all, the teaching capacity for producing a steady stream of graduates in biotechnology. The country currently has around 8000 biotech students and 1300 graduates in the subject. There are 21 university biotechnology faculties, seven of which offer doctoral studies in the discipline. The government is trying to exploit this human capital in biotechnology by offering investment grants for biotech projects on the basis of the number of jobs being created and the amount of R&D which will be conducted.

In addition, the EU is offering financial support for biotech projects to aid development in regions like the CEE. Along with several other Eastern European countries, Poland joined the EU in 2004. Currently there are around 70 biotechnology companies in Poland, most of them in biopharmaceuticals and diagnostics, with annual revenues of around $100 million. The majority are located in emerging clusters in Warsaw, Lublin, Krakow, Wroclaw, Poznan, and Gdansk, where there are universities and research institutes specializing in life sciences and biotechnology. Most of the biopharmaceutical companies are concentrating on the discovery and development of new drugs as well as small-scale contract manufacturing. A few are dedicating themselves to the development and production of their own biopharmaceuticals, above all biosimilars.

"Biosimilars have better prospects since Poland has a chance to specialize in this area rather than in purely innovative biotech products," says Monika Stefanczyk, head pharmaceutical market analyst at PMR Ltd., a Polish market research company.

The three main players in the fledgling biosimilars sector are Mabion, formed five years ago by a consortium of four pharmaceutical and two research companies, Polpharma, Poland's largest domestic pharmaceutical producer, and Bioton Group, which has been active in setting up foreign partnerships. Mabion, whose R&D work at its Lodz site has been aided by EU funding, is working on several projects, mostly oncology treatments. Two are monoclonal antibody drugs which the company believes will assist it in gaining a foothold in a world market for humanized monoclonal antibodies predicted to be worth $60 billion by 2015.

Mabion has a proprietary technology, which it claims enables it to make the drugs 30 to 40 % cheaper than conventional methods. Polpharma, which has formed a specialist unit, Polpharma Biologics, for the development and production of biological products, was scheduled to open a laboratory in the first quarter of this year in Gdansk. The laboratory includes scale-up equipment for production of clinical trial batches and a pilot plant.

Warsaw-based Bioton signed a €55.5 million ($73 million) deal with the Icelandic generic-drug company Actavis in February for the development and manufacture of recombinant human insulin (RHI) products, which Actavis will market throughout Europe and in the US. Just how many other Polish companies join these three front-runners in biopharmaceuticals could depend on the availability of private funds to supplement public-sector finance.

"Access to private money is a bit easier but it is still difficult to find investors willing to put money into biotechnology," says Marcin Los, chief executive of Phage Consulting, in Gdansk, which is encouraging the development of a niche bacteriophage segment in Poland. Biotechnology scientists and entrepreneurs in Polish biotechnology, including in biopharmaceuticals, claim that another barrier is proposals to tighten up the country's already restrictive legislation on genetically modified organisms (GMO).

"Planned amendments to the regulations fail to take into account the ability of GMO research to be carried out in labs in controlled conditions without any risks to the environment," says Professor Tomasz Twardowski, vice-president of the Polish Federation of Biotechnology. "The new rules handicap Polish biotechnology in comparison to regulatory conditions in other countries. The Polish government is responding to public opinion hostile to GMOs rather than taking note of the scientific evidence." Polish biotech companies argue that the government cannot have it both ways. It cannot expect to have a thriving biotech sector while having legislation which hampers its activities.

Sean Milmo is a freelance writer based in the UK.