Nanomedicines (NMs) offer numerous, potentially game-changing features for 'smarter' drug delivery technology; and their development and commercialization has been of the subject of intense interest for over two decades. Key features promised by NMs include circumvention of solubility and bioavailability issues of otherwise failed or only minimally effective drug candidates, improved tissue targeting and tailored controlled-release properties. If they can live up to the promise, NMs could become key therapeutics in numerous disease areas.
Abraxane (albumin nanoparticle stabilized paclitaxel; Celgene), which, in 2005, became the first non-liposomal NM to receive FDA approval, will see its first FDA Orange Book patent expire later this year. The case of Abraxane is unique from an intellectual property (IP) perspective: following Allergan's FDA filing for a generic version in March of this year, Abraxane has become the first NM to face an accelerated new drug application (ANDA) challenge. A complex regulatory and legal dance, which is an increasingly regular occurrence in the pharmaceutical market, is now expected to begin between the generic challenger, the innovator, and the FDA; yet this case (and those that follow) will likely be marked by a number of challenges unique to these so-called 'nanosimilars'. The term “non-biological complex drugs” (NBCDs), used to categorize NMs in the regulatory field, highlights the fact that pharmacokinetic properties of NMs are inherently tied to the physicochemicalproperties of the carrier itself (size, shape, composition and polydispersity), and these properties, in turn, are highly correlated with the manufacturing processes employed to prepare NMs. However, in contrast to recent guidelines put in place for biosimilars, methods for establishing bioequivalence of NMs to an innovator product are not yet clearly established.
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