Pharmaceutical Executive Europe - September 2006 - (Page 17)

The Evolution of Biosimilars A look at the legislative hurdles and opportunities for progress facing this vibrant new sector of the generics market. using Eli Lilly's Humatrope as the reference medicine iosimilars also known as follow-on protein Conrad Savoy B and Omnitrope's reference medicine is Pfizer's products or biogenerics are generic versions of is head of pharma Genotropin. biopharmaceutical products. Depending on the development hGH at expression system used and the large-scale BioPartners GmbH, Target biopharmaceuticals manufacturing process of the molecule they Switzerland. are not necessarily chemically identical.1 Full data protection on medicinal products for human use has been cut from 10 years to 8 years, giving Even though the primary amino acid sequence competitors access to the originator's data 2 years may be identical, slight differences can emerge based before patent expiration.2 It is only a matter of time on the expression system and the conditions used to manufacture the active ingredient. Such slight before certain key patent expirations will allow differences are more likely to be expected in the manufacturers to work on biosimilars of the eight more complex molecules, for example erythropoietin major biopharmaceuticals: as it is glycosylated , and are less likely in the more Er ythropoietin for the treatment of anaemia simple proteins such as insulin and human growth resulting from chronic renal failure or from cancer hormone hGH . chemotherapy. Earlier this year, Sandoz's Omnitrope and Human growth hormone for treating growth Biopartners' Valtropin became the first biosimilars to hormone deficiency and other conditions causing receive marketing authorization from the European poor growth. Commission EC , followed closely by Omnitrope Inter feron several varieties of interferon are used receiving approval from FDA. Omnitrope is also in therapy for a variety of disorders including available in Australia, where it was launched in multiple sclerosis, viral hepatitis and a number of November 2005. types of cancer. Both Omnitrope and Valtropin are biosimilars of Insulin for the treatment of diabetes. somatropin, a recombinant human growth hormone Granulocyte Colony Stimulating Factor G-CSF rhGH . Human growth hormone is normally secreted used to accelerate recovery from neutropaenia. by the pituitary and induces growth as well as exerting Granulocyte -Macrophage Colony Stimulating Factor beneficial metabolic effects. Valtropin was developed GM-CSF stimulates the production of white 17

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - September 2006

European Overview: Competition Time
Growth Strategies: Survival of the Fittest
Pharma Defence Strategies: Fighting Fire with Fire
Biogenerics: The Evolution of Biosimilars
Branding and Marketing: What's in a Name?
Branding and Marketing: A New World Order
Legal: Balancing Acts
Q&A: Champion of Industry
Q&A: Courting Consolidation
Market Outlook: Top Five Trends

Pharmaceutical Executive Europe - September 2006