As more modern drugs are created by biologic, rather than chemical, means, a set of proposed guidelines from the U.S. Food and Drug Administration this week suggests that making cheaper generic versions of those biologic drugs will be a lot more difficult.
Maria Zacharakis, a partner at Boston law firm McCarter & English, said in an interview that the FDA has repeatedly talked about taking a “stepwise” approach to coming up with regulations surrounding biosimilars. “They are taking their time, and looking at this very carefully,” she said. Comments on the guidelines released this week will be accepted until August, after which the agency can either issue new draft guidelines or the final rules.
But Zacharakis said the draft guidelines indicate several ways that the drug innovators may be able to ward off competition from biosimilars. The guidelines say that in order to show a new drug is a biosimilar to an existing one, the generic drugmaker will likely have to prove it’s similar in terms of both pharmacodynamics and pharmacokinetics — the study of what the body does to a drug, and what a drug does to the body. The exact methods of measuring both those properties (for instance, biomarkers used to gauge pharmacodynamics) can be patented, thereby making it impossible to prove similarity until those patents expire. Such patents would likely be applied for years after the original patent for a drug, effectively extending it significantly, she said.
Such a case would favor drug innovators, arguably giving them more of an incentive to develop groundbreaking new drugs by allowing them to charge more for a longer period of time.
“Pragmatically speaking, this is what the innovator companies are trying to do in the interest of their investors,” Zacharakis said.
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