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Biocon targets emerging, developed markets with biosimilars

Biocon targets emerging, developed markets with biosimilars

NEW DELHI: Biopharmaceuticals firm Biocon is looking to tap opportunities in biosimilars targeting diseases such as diabetes and cancer among others, in both emerging and developed markets.

The company expects regulatory filings in the US and Europe by 2016-17 for some of its biosimilars out of the five development programmes that it is currently undertaking with pharma firm Mylan.

Biosimilars are types of biological products that are used for treatment of various diseases.

“Biocon aims to provide high quality biosimilars to patients across the world, both in emerging and developed markets,” Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw told PTI.

Giving an update on the progress of the company’s biosimilars programmes, she said: “The clinical development of five biosimilars programmes in partnership with Mylan is progressing well.”

The clinical advancement of these programmes has put the company on track for regulatory filings for some of these in the US and Europe in FY17, she added.

Biocon had launched its biosimilar Trastuzumab in India in 2014 as CANMAb for treating metastatic breast cancer.

“We expect the clinical progress in biosimilars and novels to augur well for the company, going forward,” she added.

Commenting on market opportunities, Shaw said: “Emerging markets present an important opportunity for Biocon. We are already addressing the large need for affordable insulin therapy in India and several emerging markets through our generic recombinant human Insulin (rh- Insulin) and Insulin Glargine.”

She further said: “We are working on enhancing the emerging markets footprint for our biosimilars even as the clinical development of these molecules progresses in developed markets.”

The company already has marketing approvals in over 60 countries for rh-insulin and in over 20 countries for insulin Glargine, she added.

Earlier during the year, Biocon had received regulatory approval in Mexico for insulin Glargine, which was the first product to be approved as per the biocomparable guidelines defined by the Mexican health authority in 2012.

Patient recruitment in the insulin Glargine global phase-III trials were completed in the first quarter of this fiscal.

Patient recruitment for multi-centric global phase-III clinical trials for Pegfilgrastim and Trastuzumab are nearing completion, Biocon said.

“Global Phase-III clinical trial for Adalimumab is progressing well across multiple sites. Global Phase-I PK study for Bevacizumab is approaching completion while the ROW focused Phase-III trial is advancing as per plan,” the company added.

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