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Can Human Growth Hormone Be Genericized?

Genentech solidified its grip on the $350 million US market for human growth hormone through aggressive marketing, creative value-added services, and savvy timing. But a crop of new competitors, waiting for FDA approval of their nearly identical versions of the drug, are likely to change the basis of competition and most importantly, make pricing an issue.

Since 1985, when Genentech Inc. introduced the first recombinant version of human growth hormone, Protropin, it has virtually dominated the business. Helped greatly by the Orphan Drug Act, which protects drugs for small patient populations from competition for seven years, Genentech has captured 70-75% of the market in the US. In contrast, Eli Lilly & Co. , which has shared the Orphan Drug exclusivity, hasn’t been able to attain more than a 25% share. Even overseas, where Orphan Drug Act protection doesn’t apply, Genentech’s marketing partner, Pharmacia AB , is the leading supplier, with more than 50% of the European market.

Genentech has attained its pre-eminence in the market through a blend of aggressive marketing, the development of creative value-added services,...

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