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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