FDA Biosimilar Plan Offers Employers Saving Strategy Solution

In 2017, biosimilars generated $3 billion worldwide in revenue and present growing market competition to the specialty biotech market. Escalating specialty drug costs present a challenge for many employers who struggle to balance health care spend with business financial livelihood.

Based on 2017 FDA research, the delayed market launch of nine biosimilars represented $4.5 billion in potential savings. As part of the FDA Biosimilar Action Plan, biosimilar drugs are poised to offer a solution that could help deliver significant cost advantages without compromising therapeutic efficacy, safety, or quality.   

Biosimilars are biologic drugs that are highly similar in structure and function to existing FDA approved reference drugs. With fully established FDA safety and efficacy data, reference drugs are used as the benchmark to which biosimilars are compared to.

For example, Neupogen is the reference drug for both biosimilar products Zarxio and Granix. Biosimilars must demonstrate no clinically meaningful efficacy differences and equal safety to gain FDA approval.

Read more about Neupogen's FDA approval here. 

Biosimilars should not be viewed as generic drugs, but rather an alternative form of brand medications that would usually be categorized as specialty.

“Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs,” Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA Center for Drug Evaluation and Research.

As part of the President Donald Trump’s efforts to reduce drug costs, the FDA has released a plan to expedite the approval and market launch of biosimilars.

FDA Commissioner Scott Gottlieb, MD, said the agency will “work with the Federal Trade Commission to stop ‘gaming tactics’ like piling up patents to extend the commercial dominance of brand-name medicines.” 

Many biosimilars gain FDA approval but few are available on the market. Once FDA-approved, biosimilar products face an extended period between the approval and product market launch. This is due to the lengthy reference manufacturing patent review process that delays the number of biosimilars available for prescribing.

Dr. Gottlieb condemned reference manufacturer maneuvers to delay biosimilars market launch, saying, “We’re not going to play regulatory Whac-a-Mole with companies trying to unfairly delay or derail the entry of biosimilar competitors…we’re not going to wait a decade or more for robust biosimilar competition to emerge.”

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