Biogenerics debate rumbles on
presented strong opposition to the concept of biogenerics at a
recent meeting convened by the US Food and Drug Administration. As
expected, their argument centred on the risk that small changes in
the manufacturing process can have a dramatic impact on the safety
and efficacy of biological drugs.
At the meeting, the Biotechnology Industry Organization - which represents biotechnology companies in the US, argued that the complexity of the biologic manufacturing process requires extensive data derived during product development to assure appropriate safety and efficacy of so-called 'follow-on' protein products.
The biopharmaceutical industry maintains that this means that companies seeking to develop generic version of biological drugs will have to carry out extensive clinical trials to demonstrate safety and efficacy, rather than rely on the more usual concept of 'bioequivalence' that applies to generic chemical-based drugs.
A statement released by the BIO notes: "A full complement of data is the set of data contained in the complete regulatory filing submitted by a manufacturer to the FDA (or other appropriate regulatory authority) sufficient to show safety and effectiveness.
In response, the FDA has asked for specific examples where changes to the production process by the originating company has led to a difference in the behaviour of the drug by creating a variant of the protein. It is also seeking information on the processes that the industry have used to identify these variants.
One concern raised at the meeting was the originator companies are seeking a hurdle for approval higher than for the original product, given that existing biologic drugs are often subject to changes in the cell culture used to make the protein and the formulation in which it is presented.
Comments on the issue of follow-on protein products are due at the FDA by 12 November.
Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s - including human growth hormone (hGH) and insulin - are set to lose patent protection in the US in 2005 and beyond. This opens up a market currently worth $30 billion (€24.5bn)and growing at 10 per cent a year - but only if a regulatory route to market can be teased out.
API and generic companies are hoping that biologicals can provide additional impetus to the strong growth being seen in the market for chemical-based generics worldwide. Biogenerics could quickly address a $10 billion market in which many treatments cost upwards of $10,000 per patient per year.