• Herceptin: phase-1 • Neulasta: preclinical • Avastin: process development • Humira: cell-line development • Enbrel*: cell-line development • One undisclosed product at an undisclosed stage
*Presumably not for US market due to AMGN’s recent patent extension.
The FoB market in India is muddied by the lack of patent protection for many branded drugs, including Herceptin. Roche couldn’t sue to block the actual selling of MYL/Biocon’s Herceptin FOB, and hence Roche had to resort to impeding MYL/Biocon’s marketing message.
This case should not be considered a harbinger of what will occur to FoB’s in the US, where the regulations are much different than in India.