Biocon to file up to five biosimilars in EU and US in FY 2017

By Dan Stanton contact

- Last updated on GMT

Biocon to file up to five biosimilars in EU and US in FY 2017

Related tags: Clinical trial

Biocon could file up to five biosimilars in Europe and the US by 2017, the Indian drugmaker says as it reports robust second quarter results.

For the second quarter fiscal year 2016, Biocon announced revenues across its biopharma, branded formulations and contract research divisions of 8.3bn INR ($127m), up 11% on the same period last year. Net profit, meanwhile, grew 200% on 2015 to just over 3bn INR.

The biopharma sector didn’t fare quite so well, seeing just a 4% growth which management attributed to slow offtake of some APIs and capacity constraints.

While the firm is addressing this situation through recent investments and expansions -  for example through the acquisition of a Vizag API plant​ and by building a new bioproduction site​ – it is biosimilars which could be a major growth factor going forwards.

“It has been a stable performance for Biocon this quarter with several growth triggers on the horizon focusing on Biosimilars in emerging markets,” ​Managing Director Kiran Mazumdar-Shaw said.

Canmab, Biocon’s copycat version of Roche’s Herceptin, became the world’s first trastuzumab biosimilar when it was launched in India in 2014​, but now this product – along with four other biosimilars in development  – could be filed in the US and European markets.

"The encouraging clinical advancement across all our programmes puts us on track for regulatory filings for some of these molecules in the developed markets of US and Europe, in FY17,"​ a Biocon spokesperson told Biopharma-Reporter.com

"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 [Amgen's Neulesta] and trastuzumab are nearing completion while the global Phase III clinical trial for adalimumab [Abbvie’s Humira] is progressing well across multiple sites."​ Furthermore, "the global Phase I PK study for bevacizumab [Roche’s Avastin] is approaching completion while the ROW focused Phase III trial is advancing as per plan."

Biocon is also pursuing a proprietary biologic in Alzumab (itolizumab) an anti-CD6 monoclonal antibody for a range of autoimmune conditions, but the firm has said it expects procedural delays in developing this molecule in the US, on account of the requirement to obtain certain Governmental clearances.

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