- Generic drugmakers Mylan and Biocon last week said the European Medicines Agency had accepted their application for approval of a biosimilar version of Roche's breast cancer drug Herceptin (trastuzumab).
- The companies have partnered to develop six biosimilars, including trastuzumab, with commercialization rights divvied up between the two.
- Herceptin is one of Roche's three top-selling cancer drugs, bringing in sales of 3.4 billion Swiss francs over the first six months of 2016. Roche also markets Herceptin in combination with another breast cancer drug called Perjeta, which has helped boost sales of both drugs.
Mylan and Biocon, along with other biosimilar developers, are eyeing the lucrative revenue streams of some of the top-grossing biologic drugs on the market. Roche markets a trio of cancer drugs—Rituxan, Avastin and —Herceptin that each earned more than 6.5 billion Swiss francs (roughly $6.6 billion) last year and are attractive targets.
In addition to Mylan and Biocon's submitted application for biosimilar Herceptin, Novartis' Sandoz unit has filed with the EMA for approval of a version of Ritxuan (marketed as Mabthera in the E.U.).
And in Japan, Amgen has partnered with Japanese drugmaker Daiichi Sankyo to develop and manufacture a number of late-stage biosimilars, including Avastin and Herceptin.
Mylan and Biocon said they believe their submission to be the first such application for a biosimilar version of Herceptin to be accepted by the European regulators.
But Roche won't be caught unawares by the filing. Roche has been anticipating the onset of biosimilar competition for some time: "We expect both Herceptin and MabThera biosimilar entrance between mid-next year to the end of next year at this stage, at least one entrant," said Daniel O'Day, Roche's chief operating officer of pharmaceuticals in a recent call with investors.
Pairing Herceptin with Perjeta is one strategy to help protect market share as biosimilars move closer to market. In a recent earnings statement, Roche attributed higher sales of Herceptin (up 5% year over year) to "increasing demand in the U.S. due to longer duration of treatment in combination with Perjeta."
Mylan, which has been under fire for steep price increases for its EpiPen treatment, also recently filed for approval of a biosimilar version of Amgen's Neulasta (pegfilgrastim).