Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India
Executive Summary
Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.
You may also be interested in...
Products Roundup - 19 December 2018: European Commission Approves Mylan/Biocon’s Ogivri Biosimilar, Amgen Files Infliximab With The FDA And Hikma Debuts Dalfampridine
The latest generic, biosimilar and value-added drug development news and highlights from across the globe.
Roche India Mandate 'Completely Different' Says New Head Bezzera
Lara Bezerra, Roche’s new managing director in India, outlines in an interview with Scrip how the Swiss multinational is now looking at the Indian market through a different lens and beyond short-term gains.
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.