Biogenerics

 

Biogenerics & Therapeutic Proteins Overview

The Competitive Intelligence Report Biogenerics & Therapeutic Proteins as of May 2007 provides a competitor analysis in the development pipelines of ten therapeutic proteins with five of them already under threat by patent expiry:

• human growth hormone ( hGH ; somatostatin ),
• Erythropoietin ( EPO ; epoetin );
• Insulin ;
• Interferon ; and
• granculocyte colony stimulating factor ( G-CS; , filgrastim ).

The report describes the market size and sales figures of the branded therapeutic proteins for 2006 and the challenges represented by biogenerics (syn.: biosimilar , follow-on biologic , follow-on protein ), improved first generation therapeutic proteins by use of delivery devices and technologies to prolong half-life such as pegylation or technologies for non-invasive drug delivery , engineered proteins, oral small molecules or new molecules with a different mechanism of action but resulting in the same pharmacologic effect.

Competitor and Markets

The report provides an elaboration of the R&D pipeline of new developments for each of the ten therapeutic proteins. Among the companies with first and second generation therapeutic proteins affected by biogenerics are Amgen, Roche, Johnson & Johnson, Schering-Plough and many more. The biogenerics pipeline of the therapeutic proteins is separately evaluated for developments in the European Union and the United States (US) and in “off-patent” countries and includes Western companies as well as companies from India, South Korea, China, Argentina and Cuba as the major contribuents of biogeneric proteins. Among these companies are Barr Pharmaceuticals, Teva, Sandoz, Bioton, Biocon, Ranbaxy, Reliance Life Sciences and many more. The report also includes next generation developments of therapeutic proteins from “first generation companies” and from companies with technologies allowing improvement of therapeutic proteins such as prolonging half-life with the need of less injections, non-invasive delivery such as inhalation, oral, transdermal or nasal administration and also more potent and potentially safer molecules.

Therapeutic Proteins New Generation

The therapeutic proteins of the first generation are also challenged by different product categories with oral small molecules of special interest in the next generation pipeline of Erythropoietin, follicle stimulating hormone ( FSH ) and thrombopoietin ( TPO agonists ). Further therapeutic proteins analyzed in the present Competitor Analysis are Coagulation Factors (Factor VIIa, F. VIII, F. IX and von Willebrand factor) to treat hemophilia and Enzyme Replacement Therapy for glucocerbrosidase, galactosidase, glucosidase, iduronidase, iduronate-2-sulfatase, N-acetyl-galactosamine-4-sulfatase to treat Gaucher’s disease, Fabry disease, Pompé disease, mucopolysaccharidosis (MPS) I, II and VI. Although current thrombolytics are of little market attractivity in the Western world, new developments directly acting on fibrin have attracted high interest in a number of therapeutic indications including ophthalmic diseases, stroke and peripheral arterial occlusive disease (PAOD).