Five Questions for Personal Genomics in 2010
Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010.
1. Will the $1,000 genome live up to the hype? Affordable whole-genome sequencing is coming, possibly as early as this year depending on whom you ask. But when the day inevitably arrives, after the media frenzy has subsided, will the $1,000 genome prove anti-climactic?
Whole-genome sequencing is a means to an end and not an end in itself. The understandable excitement surrounding Complete Genomics’ November announcement that it had sequenced three genomes for an average cost of $4,400 often neglected to focus on what the price tag did not cover: the substantial costs associated with interpreting the genomic data.
For genomics researchers, the falling cost of whole-genome sequencing is a continuing cause for celebration, enabling increasingly ambitious research projects. But the success of personal genomics, which is what really matters to consumers, patients and healthcare providers, requires more than inexpensive genomic data. The real breakthrough in personal genomics will come when we can offer individuals affordable access to their whole-genome sequence as well as to the genomic tools and knowledgebase necessary for those individuals to put that data to use.
Follow-on Biologics: How Much Incentive Do We Need?
After almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for approval of generic versions of biological drugs. Although follow-on biologics are in some ways similar to generic drugs, the differences are crucial, and in fact the regulatory scheme for generic drugs does not work at all for biologics. Congress has its work cut out for it.
Biologics 101. In short, here is the problem: typical pharmaceutical drugs (“small molecule drugs”) are chemically synthesized, and once the brand-name manufacturer’s exclusive patent rights expire, generic manufacturers are free to obtain approvals under abbreviated procedures, Generic manufacturers are generally not required to submit preclinical (animal) and clinical (human) data along with these Abbreviated New Drug Applications (ANDAs), thereby avoiding the huge expenses associated with developing new pharmaceuticals. But this route is only open to the generic manufacturer if it can prove that the generic version of the drug contains an identical replica of the drug’s active ingredient. Under the Hatch-Waxman Act of 1984, the Food and Drug Administration (FDA) may approve a generic version of a drug if the generic contains the same active ingredient as the original, shows bioequivalence to the original, and is demonstrated to be manufactured according to appropriate practices. Once these are shown, the generic is allowed to piggyback on the designation of the original drug as safe and effective.
