BIOTECH CONSULTING: Supergenerics - Pharma's Freshmaker
A traditional generic drug is essentially the same as the original drug, incorporating the active pharmaceutical ingredient (API) for which the patent has expired. It is typically approved through a simplified registration process and then sold under a common, rather than brand, name. In a typical generics market scenario, a drug goes off patent and competitors rapidly penetrate the market within weeks. This results in a significant price decrease, the product becomes a commodity, and the original drug maker suffers a sharp loss of market share and revenues.
Taking into consideration all those facts, it is not surprising that generic drug manufacturers are looking at innovation to get to the next big league - 'super generics'.
The term “supergeneric” has been given to the development process for small molecule drugs which offer a therapeutic advantage or differ from commodity generic products. While commodity generics are clones of the original drug, supergenerics represent new therapeutic entities that demonstrate improvements in methods of delivery, formulation, design or the manufacturing process. In fact, a supergeneric will sometimes need a completely new drug application in order to gain approval from the Food and Drug Administration (FDA).
On the other hand supergenerics may be able to offer a low-risk, low-cost alternative to the traditional pharmaceutical development of new medicines, due to their shorter development timeline. New Chemical Entities (NCEs) take a long time to develop, often exceeding the cost of $1billion. Conversely, the development of a supergeneric is more comparable to that of a generic compound, as it has a known mechanism of action and an established safety and efficacy profile.
Since 2004, over 245 drugs have been approved in the US, of which 70% were novel formulations and 18% were new combinations. There are currently more than 60 novel supergeneric formulations of approved oncology, CNS, pain and respiratory products undergoing development (source: GBI Research).
Because of simpler delivery system, supergenerics are more friendly for patient, thus more willingly to use for them, for instance - delivery via oral or patches, instead of injections. These methods are not only simple but also increase effectiveness. Furthermore, supergenerics can be prepared in such way, that active ingredient is liberated in longer time in comparison to generics. It causes that patient takes medicines more rarely than in case of generics. Nowadays, the “One-fits all“trend dominates. The change in the demographic composition as well as the growing demand from the pharmerging markets will create a substantial need for individualized therapeutic solutions that could be addressed by developing patient centered pharmaceutical products through “supergeneric” route. Thus increasing the therapeutic results of drug therapy and supporting the efficient use of healthcare resources.
Supergenerics are an important source for innovation in drug therapy in the coming decades.
This topic under the name “Innovation in generics” will be widely discussed on the BioForum 2013 in Budapest. The panel will focus on presenting CEE innovation potential, including the generic market which in CEE covers over 95% of the pharma industry.
BioForum - Central European Forum of Biotechnology & Innovative BioEconomy and the accompanying events will take place on 22-23rd May 2013 in Budapest. The originator and the main organizer of this event is a polish company: Bio Tech Consulting (www.biotechconsulting.eu). The Coorganizer is Hungarian Biotechnology Association.