The firm is the fourth to make the monoclonal antibody (mAb) in India, a spokesperson told us, adding: “[The] trastuzumab market includes two innovator brands and eight biosimilar brands.”
Hervycta, indicated for the treatment of HER2-positive cancers, marks Dr. Reddy’s fifth biosimilar to launch in India, joining versions of MabThera (rituximab), Neupogen (filgrastim), Neulasta (pegfilgrastim), and Aranesp (darbepoetin alfa).
In 2013, Biocon and Mylan became the first companies to receive Indian regulatory approval for a trastuzumab biosimilar.
However, in 2014, Roche instigated an injunction against Mylan and Biocon to stop their trastuzumab products, marketed as Hertraz and Canmab respectively, being compared to its branded drug Herceptin.
The injunction restricts either Hertraz or Canmab from being referred to Roche’s Herceptin in “data relating to its manufacturing process, safety, efficacy and sales, in any press releases, public announcements, promotion or other material for the defendants’ drugs.”
A Roche spokesperson confirmed the injunction still stands, but declined to comment on its position regarding Hervycta.