FDA, Patent Office at Odds on Biosimilars: CBS News Report

As FDA works to streamline biosimilar approvals, the U.S. Patent and Trademark Office is creating new barriers that will slow the process of bringing the drugs to market. That’s the conclusion of a CBS News report republished by KFF Health.

The report says drug industry officials reacted positively to FDA commissioner Marty Makary’s 10/29 announcement that he said would cut by 50% the time and money needed to bring biosimilars to market.

A proposed agency guidance says FDA would begin overseeing biosimilars in the same way that it regulates generic, small-molecule drugs. The article quotes an executive with a German firm that makes biosimilars as claiming that the change “could allow companies to save up to $100 million for each drug they develop, enabling them to make more products for underserved patients.”

But, CBS says, biosimilar makers charge that the patent office is working at cross-purposes with FDA by narrowing the opportunities for companies that try to challenge the many patents that innovator companies get approved for their biologic products.

In the past, it says, biosimilar makers have been able to invalidate some of the patents through a sped-up process called inter partes review (IPR). But the office is now denying most IPR requests and has issued a proposed rule to make IPRs harder to obtain.

UCLA pharmaceuticals policy researcher William Feldman told CBS that FDA regulation is often the least of the three major hurdles the biosimilar industry faces in marketing its products. Industry executives say the “patent dance” that occurs when biosimilar makers want to launch competitor drugs can last for years. While Makary has blamed FDA red tape for those delays, the report says, in fact,

they were mostly due to the baffling patent rules.

The report says that major drug companies favor the patent office’s swing toward more protection of filed patents. But Stanford Program in Law, Science & Technology director Mark Lemley says he doesn’t think the Trump administration has a coherent plan. While Trump officials want to bring down drug costs, he says, “they also want to make it more expensive to figure out whether patents are valid by effectively eliminating IPRs.” The patent office did not respond to CBS’ phone calls and emails.

Patents and patent litigation are the biggest impediment to getting biosimilars onto the market, according to UCLA’s Feldman.