Stakeholders Urge FDA to Pass Final Guidance on Biosimilars at Recent Conference, AIS Newsletter Reports

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Biosimilar stakeholders urge the FDA to pass final regulations related to the drugs at a recent conference on biosimilars, reports Atlantic Information Services’ Specialty Pharmacy News in its December issue.

The December issue of Atlantic Information Services, Inc.’s (AIS) Specialty Pharmacy News (SPN) offers coverage of a recent conference on biosimilars, drugs that are highly similar to and less expensive than brand-name biologic drugs and use an abbreviated pathway for the Food and Drug Administration’s (FDA) approval. At Rx Innovation: A Discussion on Biosimilars, Patient Access & Affordability, representatives and stakeholders from across the health care industry – from government officials to executives from pharmaceutical companies — focused particularly on the status of the FDA’s biosimilars guidance, with all panelists urging the FDA to issue final regulations on biosimilars.

Speaking at the conference, Sen. Richard Blumenthal (D-Conn.) and Rep. Gus Bilirakis (R-Fla.) expressed bipartisan support for biologics, SPN reports. Sen. Blumenthal called biosimilars “a tremendously important and profoundly significant subject to the future of medicine in the U.S. and to our health.” Rep. Bilirakis agreed, saying, “It benefits companies, the FDA and most importantly the patient if the FDA provides clear guidance on the issue.” The drugs “have had remarkable international success,” Rep. Bilirakis continued, and in Europe and Asia have “reduced treatment costs by 40%....Competition lowers prices. It’s the free market at work.”

Steve Miller, M.D., senior vice president and chief medical officer for Express Scripts, one of the conference’s co-hosts, urged the FDA to put out guidance to address issues such as whether indication extrapolation would be allowed and how the biosimilars will be named, SPN reported. He also said it will be important to know how CMS will reimburse for these drugs. “Many biosimilars are administered in a doctor’s office,” he said, “so how CMS chooses to reimburse for them will be crucial in their uptake.”

The FDA’s Sally Howard, deputy commissioner for policy, planning and legislation, said the agency is of the opinion that “no additional guidance is needed before a product [can be] approved,” also asserting that the six draft guidances FDA has released so far should help “the industry to understand the data they’ll need to submit to demonstrate biosimilarity,” SPN reports. David Gaugh, senior vice president of sciences and regulatory affairs for the Generic Pharmaceutical Association, agreed with Howard’s sentiments, saying that the draft guidance “gives us the end goal we need to get to.…I think we’ll see several filings in the coming months.”

Visit to read the article in its entirety, including commentary from executives at America’s Health Insurance Plans and the Generic Pharmaceutical Association.

About Specialty Pharmacy News
Specialty Pharmacy News is a monthly newsletter packed with business news and management strategies for containing costs and improving outcomes related to high-cost specialty products. Designed for health plans, specialty pharmacies, PBMs, pharma companies, providers and employers, the hard-hitting newsletter contains valuable insights into benefit design tactics, specialty markets for certain conditions, formulary decisions, merger and acquisition activity, payer-provider partnerships, patient adherence strategies, and new products. Visit for more information.

About AIS
Atlantic Information Services, Inc. (AIS) is a publishing and information company that has been serving the health care industry for more than 25 years. It develops highly targeted news, data and strategic information for managers in hospitals, health plans, medical group practices, pharmaceutical companies and other health care organizations. AIS products include print and electronic newsletters, websites, looseleafs, books, strategic reports, databases, webinars and conferences. Learn more at

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Jill Brown, Executive Editor
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