AIS Newsletter Tracks Latest Developments in Biosimilars Market as FDA Accepts First Application

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The August issue of Atlantic Information Services’s Specialty Pharmacy News offers coverage of recent developments in the biosimilars specialty pharmacy segment, including the Food and Drug Administration’s recent acceptance of a biosimilar application, the first step towards approval.

Biosimilars, which are similar versions of branded biologic drugs that are approved through an abbreviated process, could reap billions in health care savings. The August issue of Atlantic Information Services, Inc.’s (AIS) Specialty Pharmacy News offers coverage of recent developments in this segment, including the Food and Drug Administration’s (FDA) recent acceptance of a biosimilar application, the first step towards approval.

Drugmaker Sandoz said July 24 that the FDA had accepted its application for biosimilar filgrastim, making it the first company to disclose such information. Industry expectations are that approval could come next year, ushering in a new era of potential cost savings through greater competition in the U.S. Almost three weeks later, South Korea-based bio-pharmaceuticals company Celltrion Inc. issued a press release saying that it had “completed the filing procedure” for FDA approval of a monoclonal antibody biosimilar, but did not clarify if the application had been accepted or not.

The filing is important from a biosimilar industry perspective because “the U.S. is the largest biosimilar market in the world,” Kate Keeping, senior director of biosimilars research at BioTrends Research Group, tells SPN. BioTrends estimates that in 2022, the U.S. biosimilars market will be about $11 billion, with $9 billion in health care savings. Most experts agree that biosimilars in general will be priced at a 20% to 30% discount to the reference products.

“There is a market need in the U.S. for competition in the biologics area given that specialty drug costs are expected to be in double-digit growth,” says Tanisha Carino, executive vice president and head of strategic advisory and research services at Avalere Health LLC. And with more patients paying coinsurance instead of copays, Carino continues, “The acceptance for the first biosimilar applications by FDA…will be a first glimpse at whether these new entrants will be readily adopted by health care providers and promote the level of competition that may bring down costs to the system and increase access.”

The filgrastim filing also shows industry acceptance of the biosimilar pathway, Keeping says. “In the past, there has been the insinuation that it would never be used” because of factors such as the FDA’s being “slow in issuing guidance” and the intellectual-property issues requiring biosimilar manufacturers to “disclose their entire dossier to the reference company.”

Visit to read the article in its entirety, which also includes tips on how payers should be taking action on handling biosimilars, and analysis of biosimilar use outside of the U.S.

SPN’s August issue includes three additional articles on biosimilars’ likely impact on payers. Visit for more information.

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
Atlantic Information Services
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