O ulepszonych generykach, czyli supergenerykach
The market for standard generics may look bleak but there are opportunities for supergenerics. Unlike the copycat version of the branded product with established bioequivalence, supergenerics offer a therapeutic advantage with product differentiation achieved through improved pharmacokinetics, such as with novel controlled release delivery, combination formulations, modified dosage strengths, or
different routes of administration. The development of supergenerics requires limited financial investment despite being more expensive to develop than standard generics.
The risk of failure, however, is low compared to innovative molecules; development timelines are shorter; the route to commercialization is far less complex; and there is some scope for exclusivity.
link The declining return on investment in the research and development of new chemical entities and new
biologic entities has resulted in pharmaceutical and biotechnology companies focusing on re-innovation in the form of supergenerics and biobetters. The re-innovated products offer advantages in terms of patient convenience, new
dosage form,
route of delivery,
pharmacokinetic profile, safety, efficacy, stability, manufacturing process, etc. A variety of terms used for value-added generics (supergenerics) and value-added biologics (biobetters) are discussed in this chapter. Since these re-innovated products are derived from drugs/biologics with established efficacy and safety,
their R&D involves lower risk of failure.
Oczywiście dotyczy to tylko depresji jednobiegunowej. Ryzyko jest oczywiście zawsze. Lecz jest dużo, dużo niższe niż dla leków innowacyjnych.