FDA approves first biogeneric
The lowdown: The FDA's approval of Sandoz's Omnitrope (somatropin) has taken many people by surprise, mainly because it had delayed approval for years, and all eyes were instead focused on the European approval of the drug in April. The FDA was quick to point out that the approval of Omnitrope does not establish a true pathway for all biogenerics, as Omnitrope is classed as a follow-on biologic. The European Medicines Agency, by contrast, has published guidelines for approval of biosimilars. Growth hormone was registered in the US before any legislation for biologics, and therefore these recombinant products are legally classical drugs. Congress will have to change the law to allow approval of most other generic biotechnology products, says the agency, and there has been little progress on this issue. In response to Omnitrope's approval, Genentech told the FDA that it does not want its data to be included in the knowledge base that the agency is using to create its guidance on biosimilars, and that the company wants to be able to prevent such use or disclosure before it occurs. Innovator companies hope that Omnitrope will be viewed more like the seventh growth hormone treatment on the market, but clinicians and patients might view the drug more like a generic drug, especially as Omnitrope is likely to be marketed as a substitute for branded products and sold at around 25% of the cost of existing products.
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