Earlier versions of this article about generic drugs, in referring to Tylenol and its generic version, acetaminophen, referred to Tylenol as "the original product." Acetaminophen was approved as a drug before Tylenol was marketed as a brand name.
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Biotech Campaigns for Easier Access to Generic Drug Market
The main point of contention among these bills: the length of an innovator company's "data exclusivity." Not to be confused with patents, data exclusivity is the period after the FDA approves a product during which an imitator can't rely on the innovator's clinical data for safety and effectiveness. It can run during and longer than the period of patent protection.
Insmed, along with consumer groups such as AARP and the National Organization for Rare Disorders, are lobbying for five years, the same length as chemical drug data exclusivity, to get cheaper drugs to patients sooner and spur biosimilar growth.
"These types of drugs make an enormous amount of money," Allan said regarding a longer period. "If generics come into the marketplace, it'll eradicate the monopoly. Let's be clear. This is all about protecting monopoly."
Established companies deny such a motive.
"We've always supported a pathway," said Genentech spokeswoman Megan Pace. "We just want to make sure patient safety and data protection for innovators will be a part of the bill."
Because biosimilars aren't exact duplicates of the original drugs, they don't violate the original drug's patent, enabling legal distribution before patent expiration. As a result, the Biotechnology Industry Organization, as well as the handful of biotechs that control most of the market, supports a 14-year period to allow companies to recoup their investment and conduct further clinical trials to improve the product.
"The biologics industry, even now, is largely made up of small companies that are losing money," said Sara Radcliffe, the organization's vice president of science and regulatory affairs.
And because biosimilars aren't perfect copies, patients rights groups and biotechs are asserting that patients should not be forced to take them. It is up the discretion of individual physicians, not insurance companies or pharmacies, to substitute a branded biologic for a biosimilar, they said.
Substitution has been slow in the European Union, where patients already have access to these drugs. In the first six months of introducing Omnitrope, a biosimilar growth hormone, in France, about 20 percent of new patients requiring the hormone took the biosimilar under doctors' advice, said Andreas Rummelt, chief executive of Sandoz, the generic division of Swiss drugmaker Novartis.
Last month Insmed, a spinout from the University of Virginia, brought on Bill Thomas, the former chairman of the House Ways and Means Committee, to aid its lobbying as a strategic adviser. Thomas, who played a key role in creating Medicare Part D prescription drug coverage for seniors, was intrigued by the company's progress in duplicating Neupogen.
"You don't have to create hypothetical," Thomas said. "Insmed is real. You want to say yes to these people or no to these people."
Thomas said he is doing what he can to help move legislation by the end of this Congress.