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Regulatory Focus™ > News Articles > 2019 > 11 > Is FDA Doing Enough to Bring Biosimilars to Market? Experts Discuss

Is FDA Doing Enough to Bring Biosimilars to Market? Experts Discuss

Posted 04 November 2019 | By Zachary Brennan 

Is FDA Doing Enough to Bring Biosimilars to Market? Experts Discuss

As the number of biosimilar approvals continues to rise in the US, the number of biosimilar launches continues to lag, but experts explained how this is more of a legal issue than a problem with the US Food and Drug Administration (FDA).

Chad Landmon, partner at Axinn, Veltrop & Harkrider LLP, offered an overview on Monday at the Association of Accessible Medicines’ conference in Bethesda, MD, of the biosimilar “patent dance,” which is the convoluted and often uncertain process by which the patent issues are resolved ahead of a biosimilar’s launch.

Unlike on the generic side, which has an Orange Book of patent and exclusivity data, biosimilar companies do not have an administrative record of the date of first licensure or exclusivity period, Landmon explained. He also touched on other limitations of FDA’s Purple Book and how to improve it with legislation.

“The agency can take some actions on its own, like listing exclusivities, but one of the things that would be most helpful is to require the patents to be listed and you may need some penalties for not listing those in the Purple Book, which does require Congress,” Landmon said.

On the small molecule side, there may be between one and three patents at issue, whereas with biologics, 75 patents may be at issue, and going 75-0 will be difficult for the lawyers on the biosimilar side, he noted. He also pointed to several House and Senate bills introduced in the past year that could add some certainty to the biosimilar space, although it’s unclear which ones will make their way through Congress.

In addition to uncertainty on the legal side, there is also uncertainty on the return on investment (ROI) that biosimilar developers are seeing.

Gillian Woollett, senior vice president of Avalere Health, discussed how companies may be bailing on developing biosimilars because it’s unclear how many biosimilar entrants are necessary (she offered infliximab as an example of competition not working), and if you can’t get that ROI, companies don’t want to invest $100 million to $500 million to bring a biosimilar to market.

But FDA has the authority to speed up the approvals of biosimilars, Woollett added, noting the agency can waive whatever clinical studies it deems necessary. She said FDA’s recent biosimilar action plan is “ambitious yet vague,” explaining that companies feel obligated to follow FDA guidance documents and the agency could be more proactive at taking out certain requirements.

“Interchangeability is largely irrelevant,” Woollett said, noting that it’s only for those biologics administered at the pharmacy level and not by physicians, which is a subset of biologics. She also explained how the designation could also be detrimental to insulin products and other insulin biosimilars, at least in terms of perception.

“If there’s one thing we have to deal with it’s dealing with the misinformation” on biosimilars, Woollett added, saying FDA has a responsibility to correct some of the misleading comments made by certain companies.

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