Two Biocon-Mylan biosimilar drugs enter global clinical trials

May 8, 2015 7:30 AM

Biocon, Indian biotechnology company, announced that it has made clinical progress in its partnered programs with Mylan.

The partnership has a strong portfolio of generic insulin analogs and biosimilars including monoclonal antibodies and recombinant proteins at various stages of development.

Two molecules pegfilgrastim (PEG-G-CSF) and adalimumab have entered global Phase 3 clinical trials. While the PEG-G-CSF trial is well underway, the adalimumab trial has been recently initiated.

In addition, the Phase 3 global clinical trial for trastuzumab is progressing in more than 100 sites around the world. An initial ROW focused Phase 3 trial for bevacizumab is also underway.

Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon, said, “The advancement of these programs 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.”

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 analog products and a high-value portfolio of biosimilars for oncology and autoimmune indications.

Biocon today has one of the largest generic insulin analogs and biosimilars portfolio in advanced stages of development with five molecules in Phase 3 clinical trials, glargine, pegfilgrastim, adalimumab, bevacizumab and trastuzumab.


Source: Biocon press release

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