Biocon-Mylan programmes make progress

Partnership has a strong portfolio of generic insulin analogues and biosimilars including monoclonal antibodies (MAbs) and recombinant proteins at various stages of development

Biocon, Asia's premier biotechnology company, has reported clinical progress in its partnered programmes with Mylan. The partnership has a strong portfolio of generic insulin analogues and biosimilars including monoclonal antibodies (MAbs) and recombinant proteins at various stages of development.

Two molecules - Pegfilgrastim (PEG-G-CSF) and Adalimumab, have entered global Phase III clinical trials; while the PEG-G-CSF trial is well underway, 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, the Bangalore-based company said.

Two global clinical trials for generic insulin glargine initiated in 2014, have also made significant progress, the company added. Patient recruitment for a Type-1 diabetes study has been completed ahead of schedule, while the recruitment for a Type-2 diabetes study is expected to be completed by July 2015.

'The advancement of these programmes in the clinic represents significant progress towards providing these high quality biologics to patients across the world,' said Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon. 'Together with our partner Mylan, we can build a strong global presence in generic insulin analogues and biosimilars like monoclonal antibodies and recombinant proteins to address the need for affordable access to these biologics.'

As part of a shared commitment to provide access to high quality and affordable biopharmaceuticals, Biocon and Mylan have established a strong collaborative R&D partnership for both generic insulin analogue products and a high value portfolio of biosimilars for oncology and autoimmune indications.

Biocon currently has one of the largest generic insulin analogues and biosimilars portfolio in advanced stages of development with five molecules in Phase III clinical trials: glargine, pegfilgrastim, adalimumab, bevacizumab and trastuzumab.

Companies