Buoyant Biocon Bullish On US Biosimilar Interchangeability
Ahead of an expected FDA review of its biosimilar trastuzumab later this year, the chair of major Indian biologics company Biocon is positive over the still evolving area of biosimilar interchangeability, saying new US draft guidance is “very welcome.”
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Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability
US FDA sees role for postmarketing data to help address residual uncertainties and determine additional data needs, but not as basis for securing an interchangeability designation absent a clinical, multi-switching study, draft guidance states.
Pfizer's Herceptin Biosimilar Moving Forward Amid Rising Competition
Pfizer hopes positive top-line Phase III trial data on its Herceptin (trastuzumab) biosimilar can help it tap the lucrative market in HER2-overexpressing cancers, but analysts say that therapeutic space looks increasingly crowded with no clear favorite yet in sight.
Biocon/Fujifilm Enter Lantus Biosimilar Fray In Japan
Biocon and Fujifilm Pharma have received approval for their biosimilar insulin glargine from Japan's Ministry of Health, Labour and Welfare, marking what the Indian firm termed a "huge credibility milestone" and adding further pressure on innovator Sanofi's Lantus.