FDA Criticized for Lack of Biosimilar Guidance

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By Bronwyn Mixter

Sept. 17 — Several senators Sept. 17 criticized the head of the FDA's drug center for the lack of guidance on biosimilar labeling and interchangeability.

Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, appeared before the Senate Health, Education, Labor and Pensions (HELP) Committee to give a progress report on biosimilars. She said the FDA is still working on draft guidance documents for biosimilar labeling and interchangeability and will get those out “as soon as possible.”

Woodcock said the success of traditional generic drugs didn't happen overnight and although the first biosimilar has been approved, there are still legal and policy challenges ahead.

The Affordable Care Act gave the FDA the authority to approve biosimilars, which are biological products that are approved based on a showing that they are highly similar to already-approved biological products. Yet since the law’s 2010 signing, the agency has approved only one such treatment, Novartis AG’s Zarxio, a biosimilar version of Amgen Inc.’s cancer drug Neupogen.

Zarxio wasn't approved as an interchangeable product, which must meet a tougher standard. Under the ACA's biologics provisions, a biological product that has been approved as an interchangeable may be substituted for the reference, or branded, product without the intervention of the health care provider who prescribed the reference product, the FDA said in March.

“We believe that getting to interchangeability is feasible and we will get there,” Woodcock said. She said the human immune system is capable of detecting a tiny variability in a biosimilar product and the FDA has to make sure the biosimilar doesn't cause additional harm due to unexpected immune responses.

Woodcock also said there are trade-offs involved in various labeling decisions and the FDA needs to have a labeling convention that maintains the trust of physicians.

Billions in Potential Savings

Sen. Elizabeth Warren (D-Mass.) said “drugmakers need to know the rules of the road,” and she criticized the agency for not releasing the interchangeability and labeling draft guidance documents sooner and for not issuing final versions of other guidances for biosimilars.

“Biosimilars can save an estimated $44 billion over the next 10 years but that will only happen if patients and doctors have confidence in them,” Warren said.

Woodcock said there are 57 biosimilars in development and the agency is meeting with the sponsors of those products and has issued three final guidance documents. In April, the FDA released three final documents intended to make clear the scientific and regulatory considerations for drug companies developing biosimilars.

Biosimilar Naming

Sen. Orrin G. Hatch (R-Utah) asked Woodcock about the FDA's proposed naming policy for biosimilars.

In August, the agency released a draft guidance on the nonproprietary naming of biological products, including biosimilars. The draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names in the guidance) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product. The suffix would be composed of four lowercase letters that won't carry any meaning.

Woodcock said the FDA wants to be able to uniquely identify biosimilars but that the agency doesn't want to hinder switching between products when there are interchangeable biosimilars.

CMS Billing Codes

Woodcock also was questioned about a proposed rule from the Centers for Medicare & Medicaid Services on Medicare payments for biosimilars.

The proposed rule (CMS-1631-P), released in July, would assign all biosimilars of a single reference product one Healthcare Common Procedure Coding System (HCPCS) code and would reimburse biosimilars with the same HCPCS code based on the weighted average of their average sales price under Medicare Part B.

Woodcock said the CMS billing codes are often used by the FDA to track drug products. She said that if the proposed rule is made final, the FDA and the CMS plan to develop an approach to use subcodes to distinguish among products if there are multiple biosimilars.

Physicians Weigh In

In a press release, the Alliance for Patient Access (AfPA) applauded the committee for holding the hearing.

Biosimilars can offer patients powerful results at potentially reduced prices, the AfPA said. However, questions remain about how to name these medications so that they are distinguishable from the reference biologic for prescribing, dispensing and patient-monitoring purposes. FDA guidance on the critical safety issues of indication extrapolation and medication labeling also remains unresolved, the group said.

The AfPA said it is critical that Congress stay engaged on these issued to ensure that patients have access to approved biosimilars in a manner that ensures transparency and safety.

The AfPA is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care, according to its website.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brent Bierman at bbierman@bna.com