Stakeholders Respond to Biosimilar Action Plan

After the release of the FDA’s Biosimilar Action Plan this week, many industry stakeholders have spoken out on the actions being taken by the FDA to further competition and increase biosimilar uptake.

After the release of the FDA’s Biosimilar Action Plan (BAP) this week, many industry stakeholders have spoken out on the actions being taken by the FDA to further competition and increase biosimilar uptake.

The plan is focused on 4 key areas; improving efficiency of biosimilar and interchangeable development and approval process, maximizing clarity for the biosimilar product development community, improving understanding of biosimilars among patients, providers and payers, and reducing gaming of FDA requirements and other attempts to unfairly delay market competition.

The Biosimilars Forum, who recently submitted comments to HHS in regard to the Trump administration’s drug pricing blueprint, commented on the release of the BAP, stating that it “marks an important step forward for cultivating a robust biosimilars market in the United States. [FDA] Commissioner Gottlieb has been a champion of biosimilars, and his plan would help support the development and approval of these innovative drugs in a number of key ways,” said the president of the Biosimilars Forum, Juliana Reed in a statement made to The Center for Biosimilars®.

In addition, Angus Worthing, MD, FACP, FACR, chair of the American College of Rheumatology (ACR) Government Affairs Committee, told the Center for Biosimilars® in an email that with the rollout of this plan, “ACR along with other doctors hopes that the pathway for interchangeable drug approval will be finalized in all due haste, to increase the number of safe and effective biosimilars in the marketplace.” ACR also submitted comments to HHS on the administration’s drug pricing plan earlier this week.

Steven Lucio, the associate vice president of pharmacy services at Vizient, said “The interchangeability of biosimilars and innovator drugs may be difficult at first, but they greatly expand opportunities for healthcare organizations to better manage pharmaceutical spending.” Vizient believes that biosimilars have the potential to significantly lower the high cost of biologic drugs, while simultaneously maintaining a high level of quality and improved clinical outcomes, he said.

Pharmaceutical companies Novartis, Roche, and Pfizer also announced their support of the BAP this week. A Novartis spokesperson remarked, “We believe in collaborative measures to ensure a fair approach to competition that enables access, reduces costs, and creates the space for continued innovation.”

In a statement, a Roche spokesperson said that the firm “looks forward” to engaging in open dialogue with the FDA to “ensure patient choice and access to the treatments they need today as well as a positive environment for scientific innovation that enables the breakthrough of medicines of the future.”

Additionally, though a Pfizer spokesperson noted that the release of the BAP is an important step in creating a robust biosimilars market within the United States, they also said that “more work needs to be done to tear down market barriers to biosimilars and it will require cooperation from a robust coalition of stakeholders, from Congress and insurers to the FDA, to biologics manufacturers, and the middle-men.”

Finally, CMS Administrator Seema Verma also had positive comments about the initiatives put forth by the FDA, and expanded on actions that CMS is undertaking to spur competition in the drug market. “CMS and FDA are both working to accelerate innovation in the biosimilars market—CMS has taken action to do so by providing biosimilars with separate payment code and by lowering the amount of cost sharing that low-income beneficiaries pay for biosimilars. We look forward to continuing to work with the FDA on the roll-out of the American Patients First blueprint.”

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