Xconomy.com's Richard Gayle says the Patient Protection and Affordable Care Act has given biotech everything it wants and more: tax breaks for smaller biotech companies and some simplification of the regulatory process. The Therapeutic Discovery Project Credit provides "an amount equal to 50 percent of the qualified investment for such taxable year with respect to any qualifying therapeutic discovery project," which would permit some of the costs of pre-clinical research, clinical trials and other research protocols to be reduced, Gayle says. But the more important part of the legislation is the Approval Pathway For Biosimilar Biological Products, which permits biologics to maintain 12 years of market exclusivity after FDA approval. "The biotechnology industry breathed a sigh of relief with this section’s passage because this clearly delineated time frame could have been much different," Gayle says. Not only that, Gayle adds, but the companies would also get a first look at any competitor who might be attempting to create a follow-on biologic. "Biotechnology companies developing reference therapeutics should be ecstatic with the legislation," Gayle says.
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