Healthcare Reform Gave Biotech Everything It Wanted, and More
Summary
Healthcare Reform Gave Biotech Everything It Wanted, and More Opinion Xconomy National — And so we embark on a new era of healthcare—one that may take many years to fully reach its potential for good or ill.One provides tax breaks for smaller biotechnology companies, while the other simplifies some aspects of the regulatory landscape and adds some complicated wrinkles.The noteworthy part of the legislation, Approval Pathway For Biosimilar Biological Products, provides real clarity on an important regulatory issue.This section permits biologics—the complex therapeutics produced by most biotechnology companies—to maintain 12 years of market exclusivity after FDA approval of the product.As a former VP at a biotechnology company, I would be concerned handing all the information and data required for approval of a product over to my direct competitor before I even have it on the market.