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FDA Reassures on Biosimilar Progress as COVID-19 Applications Pile Up


The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

Is the FDA a little overworked during the coronavirus disease 2019 (COVID-19) pandemic? Consider that over 270 clinical trials specifically related to COVID-19 had been launched by July 31, 2020, and more than 570 additional clinical trials are in planning stages.

But according to Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA, the federal agency can review these trials, resist the intense pressure to do things in a hurried or sloppy fashion, and get all of its normal work done as well, while still adhering to rigorous scientific and medical standards.

“The agency continues to review submissions of medical products while balancing the added workload of hundreds of additional COVID-19 related submissions,” he said.

Pace of Biosimilar Reviews

Many of the companies that have developed biosimilars and submitted biologics license applications to the FDA have paid fees to the agency and expect their product reviews to take place in a timely fashion. In a media conference aimed at reassuring the public this week, Shah promised that would happen.

“The agency remains on target to meet our user fee goals for drugs this year by reviewing and taking timely action on over 90% of branded generic and biosimilar drug applications, even during the pandemic,” he said.

There are over 70 biosimilar development projects that the FDA is involved with currently. It is also working to update a system for calculating user fees for biosimilar applications so that the FDA has sufficient revenues to complete these tasks. Previous user fee calculations have been plagued by imprecise methodology that could not clearly anticipate needs, but based fee assessments on prior years’ activity, leading to shortfalls.

So far this year the FDA has approved 2 biosimilar products for marketing, and with just 4 months left in the year it is unlikely to equal the pace set last year, when it approved 10 biosimilars.

Granted, this year is an exception, and the FDA has more on its plate than it could have anticipated at the close of 2019. Still, the break with scientific and medical restraint that led the Russian Ministry of Health earlier this month to approve a COVID-19 vaccine after it was tested in just 76 people is unlikely to happen in the United States, based on Shah’s reassurances that the FDA will do things by the book.

“The agency doesn’t sponsor clinical trials like the National Institutes of Health, nor does the agency develop tests like the Centers for Disease Control, nor does the agency invest in companies to accelerate the development of medical countermeasures, like the Biomedical Advanced Research and Development Authority. The FDA is a regulator, and as a regulator, the FDA is responsible to ensure the safety of consumers by rigorously evaluating the evidence about the benefits and risks of medical products,” Shah said.

In March, President Trump signed a $2 trillion emergency response authorization of which $80 million went to the FDA for COVID-19 response efforts, including the development of medical countermeasures and vaccines, promotion of advanced manufacturing of medical products, and monitoring of the medical product supply chain. A $3.2 billion overall fiscal 2021 budget for the FDA is under congressional review and includes an increase of $40 million from current year appropriations; however, the Alliance for a Stronger FDA has said the agency will need even more resources in the coming fiscal year. The Alliance encompasses patient advocates, trade groups, the biomedical research community, and medical community members.

Products under investigation as COVID-19 therapeutics include antivirals, immunomodulators, neutralizing antibodies, and more.

Even with such a mountain of data poised to flow into the FDA in the form of product approval applications, the agency is “prepared to review data on a real-time basis and to render judgements with unprecedented speed, while at the same time apply the same standards for safety and efficacy that we apply to all therapeutics,” Shah said.

He also promised that all review processes would be “unbiased and highly transparent.”

Past Is Prologue

Shah provided numerous examples of how the FDA has already responded with promptness and exactitude to get COVID-19 testing kits into circulation, approve the first therapies specifically for COVID-19, such as remdesivir, and ensure that enough masks and other protective equipment are distributed to medical workers and others in high-risk positions.

Although addressing COVID-19 is the primary need, there is a simultaneous effort at the FDA to thwart the circulation and promotion of counterfeit cures, an underworld phenomenon that has led to 1000 fraudulent medical products for COVID-19 so far, Shah said. The FDA has issued more than 100 warning letters to companies “selling unapproved, unauthorized, or unclear products.” It has also worked with online retailers to root out and eliminate these products to protect the public.

Many efforts are under way, he said, to shore up the FDA’s response capability and also to learn from this crisis, so that it has the infrastructure and knowledge base fully poised to get a jump on the next public health emergency.

“While all of us want the world to return to normal as quickly as possible, it's imperative that we do this process credibly and transparently and that the public has confidence in our decisions,” Shah said.

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