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12:00 AM
Apr 15, 2002
 |  BioCentury  |  Regulation

The offshore launching pads

Countdown to Biogenerics

The offshore launching pads

While the technical and regulatory feasibility of manufacturing and marketing off-patent biologics is under debate in the U.S. and the EU, generic biologics are a reality in less-regulated markets of the developing world and the former Soviet Union. Companies are building up strength in countries that do not recognize or enforce pharmaceutical or biotech product patents, treating them as test beds and springboards into more lucrative markets of Western Europe and North America.

Sicor Inc. (SCRI, Irvine, Calif.), an international generic drug manufacturer, views biologics as an important new market. In July 2001, Sicor acquired Biotechna UAB (Vilnius, Lithuania), a biopharmaceutical company with experience manufacturing and marketing recombinant proteins in eastern and central Europe. Biotechna has registered a human recombinant interferon alpha 2b product in 16 countries and a recombinant human growth hormone product in 11 countries.

To update Biotechna's manufacturing capabilities, SCRI purchased a modular protein manufacturing plant in Sweden and had it shipped to Vilnius, where it has been validated to meet EU requirements, according to SCRI President and CEO Marvin Sampson.

To produce biologic products acceptable to international regulatory authorities, SCRI last year also completed construction of a plant in Toluca, Mexico, that is dedicated to the production of finished dosage biologics.

SCRI's strategy is to continue selling interferon alpha 2b and hGH in Eastern Europe, Africa and emerging countries and "to bring these into Western Europe in 2004 to 2005 as patents expire. Our ultimate goal is to bring then into the U.S. in 2005 to 2007," according to Sampson.

Rhein Biotech N.V. (NMarkt:RBO, Maastricht, the Netherlands) has acquired a subsidiary in Argentina that manufactures and markets interferon, interleukin-2 and erythropoietin in Latin America. According to President and CEO Daan Ellens, RBO plans to use these products to develop new, improved versions and may also market copy versions...

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