Biologics Price Competition and Innovation Act: Striking a Delicate Balance Between Innovation and Accessibility

The Biologics Price Competition and Innovation Act of 2009 (BPCIA, also known as the Biosimilar Act) was signed into law in 2010 by President Barack Obama as part of the healthcare reform bill. The central mission of the BPCIA is two-fold: (1) providing sufficient incentives for continuous innovations in biologic therapies (i.e., promoting innovation); and (2) lowering the price of biologic therapies (i.e., promoting accessibility). To promote innovation, the BPCIA provides twelve-year Food and Drug Administration (FDA) exclusivity to innovator biologics. This twelve-year FDA exclusivity prevents generic biologics, also known as follow-on biologics (FOBs), from being approved. To promote accessibility, the BPCIA provides an abbreviated pathway for FOBs—the abbreviated biologic license application (ABLA). The ABLA allows FOB manufacturers to cut short the time and the expensive cost of clinical testing by referring to innovator biologics’ clinical data to establish safety and efficacy. The goal of this Note is to discuss the advantages and drawbacks of the mechanisms established in the BPCIA and to suggest modifications to strike a better balance between innovation and accessibility. Part I of this Note introduces the legal and scientific background of the BPCIA and Hatch-Waxman Act in order to engage in further analyses. Part II of this Note analyzes the competing interests of innovation and accessibility and suggests a novel six-year data exclusivity and a six-to-twelve-year market exclusivity regulatory scheme. This Note concludes that the current design of the BPCIA tips too favorably toward innovation and compromises accessibility. The suggested six-year data exclusivity and six-to-twelve-year market exclusivity regulatory scheme potentially strike a better balance between innovation and accessibility

High-temperature nanoindentation of epitaxial ZrB2 thin films

We use in-situ heated nanoindentation to investigate the high-temperature nanomechanical properties of epitaxial and textured ZrB2 films deposited by magnetron sputtering. Epitaxial films deposited on 4H-SiC(0001) show a hardness decrease from 47 GPa at room temperature to 33 GPa at 600 °C, while the reduced elastic modulus does not change significantly. High resolution electron microscopy (HRTEM) with selected area electron diffraction of the indented area in a 0001-textured film reveals a retained continuous ZrB2 film and no sign of crystalline phase transformation, despite massive deformation of the Si substrate. HRTEM analysis supports the high elastic recovery of 96% in the films.Funding agencies: Swedish Government Strategic Research Area in Materials Science on Functional Materials at Linkoping University (Faculty Grant SFO-Mat-LiU) [2009-00971]; Swedish Research Council (VR) [621-2010-3921]</p

YbPO4 crystals in as-drawn silica-based optical fibers

MCVD germanosilica glass embedded with YbPO4 crystals were for the first time drawn into optical fibers. Solution doping was used to embed the crystals in the silica soot prior to the collapsing step. We demonstrate, using scanning/transmission electron microscopes and confocal Raman microscope, that YbPO4 crystals survive not only the MCVD process but also the drawing process despite the high temperature involved (up to 2100 °C) during fabrication processes. The fiber contains 100 nm-crystals with the same composition and structure as the as-prepared crystals. During the drawing process, these crystals tend to have a preferential orientation of their c-axis along the drawing direction. These results open a new route to fabricate glass-based composite fibers containing crystalline particles without additional post heat-treatment