Recently a study was published by Teva Pharmaceutical Industries Ltd., where Alex Brill analyzes the article recently written by Duke University economist Henry Grabowski’s which explores the number of years that a biologic drug should enjoy exclusivity before a generic equivalent is introduced. The basis for this analysis is the fact that the US Congress is considering to legislate an abbreviated pathway for the FDA to approve biogeneric therapies, much like the Hatch-Waxman Act in relation to chemical equivalents (ANDA).
Biogenerics
Generic alternative drugs (a.k.a biogenerics, biosimilars) to innovative approved drugs, in the US, are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness when submitted to the FDA. Hence, the term ‘abbreviated’ pathway. The approval instead relies on data that can prove that the drug is bioequivalent, e.g. by demonstrating that the rate of absorption and the amount delivered of the active ingredients are the same as the innovator drug.
Abbreviated Pathway as Technology Platform
Conclusions suggesting an earlier introduction of competing drugs could certainly be debated when the study is sponsored by the largest generic drug manufacturer in the world (as also indicated in Patent Baristas). Generating productivity and market efficiency through competition is hardly a revolutionizing thought though, albeit an important one. However, I wonder how the concept of an ‘abbreviated pathway’ could be used as a platform for accelerating the innovative drug development process instead of ensuring that market competition is maximized.
An ‘abbreviated pathway’ for generic approval versus a new innovative drug would obviously be different than an accelerated pathway for developing completely new drugs. For instance, there exists reliable reference data for the former but no standardized reference points at all for the latter. This means that the standardization would have to be located in another layer, where in my perspective the actual methodologies and tools used would be a more relevant focus of interest, e.g. by commercializing biomarkers in different ways.
A very interesting approach is taken by the Innovative Medicine Initiative, which focuses on speeding up the principle causes of delays and bottlenecks such as; predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training. This not only opens up opportunities for big pharma (which optimally would increase the drug/invested R&D ratio), but also provides new markets and business models for biotech actors, small as well as larger ones, based on tools, data, and knowledge management. More exploration of this to come.
Tobias Thornblad
Biogenerics
Generic alternative drugs (a.k.a biogenerics, biosimilars) to innovative approved drugs, in the US, are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness when submitted to the FDA. Hence, the term ‘abbreviated’ pathway. The approval instead relies on data that can prove that the drug is bioequivalent, e.g. by demonstrating that the rate of absorption and the amount delivered of the active ingredients are the same as the innovator drug.
Abbreviated Pathway as Technology Platform
Conclusions suggesting an earlier introduction of competing drugs could certainly be debated when the study is sponsored by the largest generic drug manufacturer in the world (as also indicated in Patent Baristas). Generating productivity and market efficiency through competition is hardly a revolutionizing thought though, albeit an important one. However, I wonder how the concept of an ‘abbreviated pathway’ could be used as a platform for accelerating the innovative drug development process instead of ensuring that market competition is maximized.
An ‘abbreviated pathway’ for generic approval versus a new innovative drug would obviously be different than an accelerated pathway for developing completely new drugs. For instance, there exists reliable reference data for the former but no standardized reference points at all for the latter. This means that the standardization would have to be located in another layer, where in my perspective the actual methodologies and tools used would be a more relevant focus of interest, e.g. by commercializing biomarkers in different ways.
A very interesting approach is taken by the Innovative Medicine Initiative, which focuses on speeding up the principle causes of delays and bottlenecks such as; predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training. This not only opens up opportunities for big pharma (which optimally would increase the drug/invested R&D ratio), but also provides new markets and business models for biotech actors, small as well as larger ones, based on tools, data, and knowledge management. More exploration of this to come.
Tobias Thornblad
Posts
Tobias, you point out in the end an interesting conflict in the reasoning around this abbreviated pathway. The relation between market competition and innovation.
ReplyDeleteIt would be interesting to hear you elaborate more on that topic in a coming post since it sure is important.