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Monoclonal antibodies continue their march on the markets, optimized so-called biobetter versions of existing biologics are also gaining ground, but the rate of biosimilar approvals has seen a dramatic slowdown in recent years.
Confidential business information is commonly used to hide data about industry products from public view. Researchers, regulators and companies are currently struggling to redefine who needs to know what about commercial products and when they need to know it.
As of last month, 41 products have been granted breakthrough therapy designations by the US Food and Drug Administration—drugs against cancer, hepatitis C and monogenetic diseases predominate.
Ventures focusing on gene therapy, adoptive T-cell therapy, protein homeostasis and the microbiome are among those selected by the editors in 2013's crop of startups.
Biologics sales grew at an incredible rate during the past 18 months, especially when compared with pharmaceuticals. But with pressure on pricing and biosimilars looming, how long will it be until biologics' last hurrah?
Compared with other US public-sector research institutions, the US National Institutes of Health has contributed inventions that have had a disproportionately greater impact on the overall number of products produced, drugs granted orphan status and drugs granted priority review.