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104 were formed in 2016; 367 during 2014 and 2015. Another 551 companies were established between the years 2012 and 2014.
The ABLE study on“ India’ s Biotech Startups Ecosystem” found that over 3,000 new entrepreneurs have joined the ecosystem and at least a third of them are women entrepreneurs.
According to the study, private equity investments into these companies totaled around $ 2.6 billion and the balance came from own investments, government grants, and others like HNIs. Year 2015 was the best one attracting $ 851 million.
The BioPharma sector continues to dominate the industry, accounting for 57 percent share of the companies formed followed by BioResearch( 16 %), BioAgri( 10 %), and BioIndustrial( 9 %). Overall nearly 40 percent of the companies were involved in the manufacture of products and ingredients. About 16 percent start-ups were each into medical health instruments / appliances and R & D services respectively.
The study was done by ABLE’ s in-house research team sifting through voluminous data on company formation from ROC databases. This is the first such study to map India’ s biotech start-ups ecosystem. ABLE will soon be releasing more such studies on various other aspects of India’ s $ 40 billion BioEconomy.
USFDA accepts Mylan & Biocon’ s proposed biosimilar Pegfilgrastim for review
Mylan and Biocon have announced that the U. S. Food and Drug Administration( FDA) has accepted Mylan’ s Biologics License Application( BLA) for MYL-1401H, a proposed biosimilar to Neulasta ®( pegfilgrastim), for filing through the 351( k) pathway.
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia( low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. The FDA goal date set under the Biosimilar User Fee Act( BsUFA) is Oct. 9, 2017.
Mr Rajiv Malik, President, Mylan commented,“ We’ re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed biosimilar pegfilgrastim will complement Mylan’ s
58 BioVoiceNews | March 2017