U.S. Pharmacopeia's release of monographs on human growth hormone appears unlikely to significantly advance the debate over an abbreviated pathway for HGH follow-on products.

USP's first formal monographs on somatropin were issued in the First Supplement of the United States Pharmacopeia 28 and National Formulary 23 (USP 28-NF 23); they became official April 1.

The Generic Pharmaceutical Association touted the HGH monographs as a demonstration that somatropin can be adequately categorized and approved under a shortened regulatory pathway.

"This monograph clearly shows that the technology and the science exist to characterize some of these medicines," GPhA said. "USP's action...further supports the establishment of an abbreviated approval process for generic biopharmaceuticals."

FDA deferred a decision on Sandoz' application for a follow-on version of Pfizer's HGH product Genotropin in 2004, citing unresolved scientific and legal issues (¹ Also see "Follow-On And Wait: FDA Defers Action On Sandoz’s Human Growth Hormone" - Pink Sheet, 6 September, 2004., p. 35).

Existing USP monographs for human insulin and sargramostim (Berlex' Leukine ) have not led to approval of follow-on products, although FDA has used USP standards to establish similarity of protein-based hyaluronidase products (² Also see "Ista Tries To Void Vitrase NME Status: Will Less Exclusivity Mean More?" - Pink Sheet, 25 April, 2005., p. 31).

FDA is developing materials that could build a framework for generic biologics, but the process appears to be a lengthy one (see ³ Also see "Generic Biologics Legislation Unlikely, But Issue Not Going Away" - Pink Sheet, 16 May, 2005.).

USP's Expert Committee on Biotechnology and Natural Therapeutics and Diagnostics approved the HGH monographs following two meetings with manufacturers and FDA and public comment.

USP began developing the HGH standards in the early 1990s; USP said the process was unusually extensive in part because of the large number of manufacturers involved.

FDA's "Drugs@FDA" database lists eight currently marketed somatropin products made by six manufacturers: Pfizer's Genotropin; Lilly's Humatrope ; Novo Nordisk's Norditropin ; Genentech's Nutropin ; Serono's Saizen , Serostim and Zorbtive ; and Teva's Tev-Tropin .

USP Human Growth Hormone Monographs Issued; Generics Status Unresolved

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