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. But there are two small bits in the Patient Protection and Affordable Care Act that are immediately relevant and timely for the biotechnology industry. One provides tax breaks for smaller biotechnology companies, while the other simplifies some aspects of the regulatory landscape and adds some complicated wrinkles.
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,” permitting some of the costs for pre-clinical research, clinical trials and other research protocols to be reduced. It appears that it will be limited to organizations with fewer than 250 employees. The total amount of the credit is $1 billion.
A billion dollars is not chump change but could disappear pretty rapidly when clinical trials are included. This credit will be helpful for the right companies but it seems to be a one-time shot in the arm.
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.
The biotechnology industry breathed a sigh of relief with this section’s passage because this clearly delineated time frame could have been much different.
The Federal Trade Commission had felt that no additional period of exclusivity was required. The Generic Pharmaceutical Association (GPhA) wanted only a five year period. President Obama wanted seven years. The Biotechnology Industry Organization (BIO) wanted at least 12 years. In the end, BIO got exactly what it wanted.
This uncertainty has been eliminated. Biotechnology companies now have a known period of market exclusivity post-approval, one that is independent of patent time frames. This will provide investors with the predictability they crave when they project product sales far into the future for biotech drugs in development.
The generic companies may be happier with another part of this section, though. As the title suggests, it describes the approval process for follow-on biologics—biological copycat molecules that have similar activities to innovative therapeutics already on the market. Until this legislation, there was no practical way for a generic company to make a “biosimilar” drug without incurring many of the same costs as the original innovative biologic. This new route to the market could be very helpful to the generic makers, but only if they can navigate the treacherous pathway … Next Page »
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