PEG-G-CSF and Adalimumab enter phase II while patient recruitment for one insulin Glargine phase II study is complete
Biocon has made clinical progress in its partnered programmes with Mylan, which span generic insulin analogs and biosimilars including monoclonal antibodies (MAbs) and recombinant proteins at various stages of development.
As per a release, two molecules, Pegfilgrastim (PEG-G-CSF) and Adalimumab, have entered global Phase III clinical trials. While the PEG-G-CSF trial is well under way, the Adalimumab trial has been recently initiated.
In addition, the Phase III global clinical trial for Trastuzumab is progressing in more than 100 sites around the world. An initial ROW focused Phase III trial for Bevacizumab is also underway.
Two global clinical trials for generic insulin Glargine initiated in 2014, have also made significant progress. The patient recruitment for a Type-I diabetes study has been completed ahead of schedule, while the recruitment for a Type-II diabetes study is expected to be completed by July 2015.
Dr Arun Chandavarkar, Chief Executive Officer and Joint Managing Director, Biocon, said, “The advancement of these programmes in the clinic represents significant progress towards providing these high quality biologics to patients across the world. I am confident that, together with our partner Mylan, we can build a strong global presence in generic insulin analogs and biosimilars like monoclonal antibodies and recombinant proteins to address the need for affordable access to these biologics.”