Beyond biogenerics: the real threats for therapeutic proteins

BARCELONA, Spain | April 24, 2007 | The Business Intelligence firm La Merie S.L. reported today that the consolidation process in the biogenerics industry has commenced after first approvals of biogeneric human growth hormone products in the US and the EU and first filings of biogeneric erythropoietin and insulin in the EU. Smaller biogeneric companies have been taken over by generic players from India and Eastern Europe . Large generic and hospital specialist companies have entered the field by acquisition and licensing deals. Apart from biogenerics, the US$ 42 bln market of the major therapeutic proteins (EPO, insulin, coagulation factors, interferons, G-CSF, hGH, enzyme replacement and FSH) is being challenged by competitor projects arising from various technologies. Oral small molecules or oral delivery of packaged or engineered proteins can bypass conventional next generation solutions such as pegylation, fusion proteins or non-invasive drug delivery technologies. These results and more were found in a competitor analysis conducted by La Merie Business Intelligence. The competitor analysis of Biogenerics & Therapeutic Proteins can be acquired at pipelinereview.com , La Merie 's News Center and Online Store.

Manufacturing of biopharmaceuticals is getting a commodity in non-regulated countries as local investors paid for technology transfer and infrastructure. Countries such as Egypt , Tunisia and Iran are joining pioneer countries such as Argentina , Cuba , India , South Korea and China which so far service domestic and other non-regulated and less developed countries. Indian companies such as Biocon now are on the move to the European Union with biogeneric proteins and are favored by a less costly local, yet GMP approved infrastructure. Biogeneric proteins not only may directly compete with first generation therapeutic proteins, but also serve for drug delivery solutions requiring larger amounts of protein. Cost-efficient manufacture by an advantageous infrastructure or less expensive expression systems may become crucial in future market competition.

The major therapeutic proteins are not only being challenged by biogeneric developments in the Western countries, but also by innovative investigational new drugs. A state of the art approach is pegylation or glycopegylation of the parent protein, but protein engineering technologies may lead to the same effect of a longer half-life and also result in improved pharmacodynamic properties. Oral delivery approaches for hGH, insulin, and interferon are currently being evaluated while oral small molecules stimulating thrombopoiesis or erythropoiesis are already in advanced clinical testing. The use of clinical stage peptide agonist or peptibody molecules are an alternative to proteins such as EPO or TPO. Progress in protein engineering and expression made available recombinant plasmin becoming an attractive alternative to plasminogen activators because it directly degrades fibrin, but yet is readily neutralized.

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SOURCE: La Merie Business Intelligence