Biocon set to seek USFDA approval for biosimilarshttps://indianexpress.com/article/business/business-others/biocon-set-to-seek-usfda-approval-for-biosimilars/

Biocon set to seek USFDA approval for biosimilars

Biosimilars are copies of biological drugs with same safety and efficacy as original products. The addressable market for Biocon in these countries is more than $30 billion.

India’s largest biopharma company, Biocon, is gearing up to enter the regulated markets of the US and the UK with a portfolio of biosimilars. The company is in advanced stages of completing global phase-III trials for four out of nine biosimilar programmes in partnership with Mylan, a US-based drug maker.

“Based on the clinical advancement thus far, the Biocon-Mylan biosimilars partnership is progressing well towards four regulatory filings in the US and EU in this calendar year,” Kiran Mazumdar-Shaw, chairperson and MD of Biocon, said.

Biosimilars are copies of biological drugs with same safety and efficacy as original products. The addressable market for Biocon in these countries is more than $30 billion. “These filings should provide us with an early mover advantage for these products in these key developed markets,” Mazumdar-Shaw said. She said Biocon will be filing for regulatory approvals in these markets in a phased manner during 2016 for four biosimilars — Trastuzumab (to treat breast cancer), Pegfilgrastim (for chemo-induced Neutropenia), Adalimumab (for chronic plaque psoriasis) and Insulin Glargine.

[related-post]

The company has made huge investments on research and development to develop biosimilars along with Mylan. It entered into a partnership with Mylan in 2009 for joint research and development of a variety of biosimilar molecules for global markets.

Advertising

“As an innovation-led company, high R&D spends are inherent to our business. We have said our biosimilars programs for Trastuzumab, Pegfilgrastim, Adalimumab and Insulin Glargine continue to cross critical milestones in global phase-III clinical trials,” Mazumdar-Shaw said.

Biocon invested Rs 169 crore in FY14 and Rs 329 crore in FY15 in R&D. In the first nine months of FY16, gross R&D expenses stood at Rs 275 crore. However, she refused to comment on the exact timeline for securing approvals in the US and the EU. “It’s difficult for us to predict regulatory timelines, but we are confident of being among the first wave of biosimilars players to enter global markets,” she said.