A US federal judge has ordered the Food and Drug Administration to deliver a verdict on a version of human growth hormone developed by Novartis' generics subsidiary Sandoz that is a copy of Pfizer's Genotropin (somatropin) product.
The product, called Omnitrope, is a so-called 'biogeneric' product, more accurately referred to as a 'follow-on biologic' in the USA or 'biosimilar' in Europe, which have proved a headache for regulators.
But with Sandoz on the brink of becoming the first company to successfully bring a biogeneric to market in Europe, all eyes are on the FDA's lack of progress in regulating the sector.
The main problem for the agency has been the lack of a defined regulatory route to approval for these products, mainly because it is not possible to make a biologic by one production process that is completely identical to another using a different process. This means that classical notions of bioequivalence - which underpin the generic drug market - do not apply.
Europe cleared its regulatory framework last month, although there are still some areas of contention, notably the generic names of biosimilar drugs, pharmacist substitution of a biosimilar for an innovator product, confidentiality of innovator dossiers and the balance between pre- and post-marketing studies in supplying safety and efficacy data.
But the FDA is lagging far behind, saying that it will not finalise its own guidance on approval criteria for follow-on biologics until a voluntary code of practice has been developed by industry.
Source: PharmaTimes
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