BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade BioSimilar, Congress Asks Tough Questions of FDA and CMS

 

Yesterday an FDA Advisory panel overwhelmingly recommended the Celltrion/Pfizer biosimilar Remsima 21-3 for approval for all the clinical indications for Jannsen’s Remicade including (RA, AS, PsA, PsO, adult CD, pediatric CD, adult UC). The discussions were straight forward outlining just how similar the two products really were.

This is only the second biosimilar to get an advisory committee. But given the FDA’s staff enthusiastic analysis of the clinical program and the advisory panels whole hearted validation for all the questions before the panel we can expect to see the flow of biosimilar applications and approvals start to accelerate.

Congress

While Martin Shkerli was busy making fun of congress for discussing his Wu Tang album at the Government Oversight committee hearing. The real work to reduce drug prices was being held at the same time in the Committee on Energy and Commerce Subcommittee on Health, entitled, “Examining Implementation of the Biologics Price Competition and Innovation Act.” The hearing was an opportunity for the Congress and the general public to get an update from the Food and Drug Administration (FDA) on the regulation and approval of biosimilars, as well as an update from the Centers for Medicare and Medicaid Services (CMS) on the recent reimbursement policy.

In 2010, the Biologics Price Competition and Innovation Act was enacted to establish a new and abbreviated approval pathway at the FDA for biological products that are determined to be “biosimilar” to or “interchangeable” with an already-FDA licensed product. In 2012, the Biosimilar User Fee Act was enacted to support the FDA’s work related to the development, review, and approval of biosimilar products. The FDA has continued to issue guidance documents on key policy considerations, and in March 2015, the FDA approved the first biosimilar in the United States. CMS, in preparation for biosimilars entering the market, has published final rules that set the stage for how Medicare will reimburse for biosimilar products.

The Contentious Hearing

Throughout the hearing, members of Congress were fairly critical about the pace at which the FDA is approving biosimilars and how Medicare plans to reimburse for them. Committee members asked Janet Woodcock, MD, the Director of the Center for Drug Evaluation and Research, and Sean Cavanaugh, Deputy Administrator and Director of CMS’ Center of Medicare, whether the two agencies had ever discussed the differences between generics of small-molecule drugs and biosimilars of large-molecule biologics.

Throughout the hearing, the subcommittee reviewed the ways that differentiate biosimilars and their regulation. Congress was concerned that the unique qualities of biosimilars are not being properly considered by CMS, and that the existing payment policy could negatively impact biosimilars that enter the market in the future, or even ultimately, wind up limiting beneficiary access and negating program savings.

Congressman Joe Barton, for example, one of the authors of the Biologics Price Competition and Innovation Act, seemed troubled that the CMS payment system for biologic drugs may discourage competition and that the FDA has not moved quickly enough to finalize a naming convention or issue guidance to manufacturers of biosimilar medications. His comments sounded a bit like a disappointed teacher, “As to how you’ve been doing with biosimilars, I would give FDA a C plus, maybe a C minus, and CMS a D. The only reason I haven’t given you an F is because you’re trying, you got something out there.”

He further commented that, “today, we sit as a subcommittee with numerous concerns about the implementation – or more appropriately, the lack thereof – of this important piece of legislation. Only one biosimilar has been approved, and numerous products are waiting to proceed through the approval process, and many physicians, patients, and concerned individuals like myself are concerned with the lack of progress.”

CMS Reimbursement Policy

The current CMS policy, published in November 2015, allows for biosimilars to be paid for, depending on the average sales price, using six percent of the reference product price as the add-on, and also groups all biosimilars that share the same reference product, with each product being reimbursed under the same code.

This creates concern because, as Rep. Frank Pallone, Jr., stated, it “treats biosimilars like generic drugs” and runs the risk of “disincentiviz[ing] manufacturers from entering the biosimilars marketplace.” Pallone also reminded Congress and the witnesses that Medicare Part D and Medicaid both acknowledge the difference between biosimilars and generics in their own programs.

Congressman Joe Barton also asked Sean Cavanaugh whether or not the agency has plans to revisit how biosimilar drugs are priced. Cavanaugh simply stated that, “From a clinical perspective, CMS knows that biosimilars are not the same as generics. From a regulatory perspective, there are similarities. Consequently, we created similarities as to how biosimilars and generics are priced,” and that CMS will be monitoring the market closely and that rulemaking could be possible in the future.

FDA’s Delay

The Subcommittee was also displeased with the way the FDA has worked to implement the BPCIA, since only one biosimilar has been approved. The FDA has been dragging its feet on implementation, but Dr. Woodcock claimed that, “We’ve seen a lot of progress since 2010, although most of it has been under the hood. We did approve the first biosimilar in 2015, and on Feb. 9, 2016, FDA’s Arthritis Advisory Committee is scheduled to hold a meeting to discuss a biosimilar to Remicade (infliximab), a biological product licensed by FDA to treat conditions such as rheumatoid arthritis, ulcerative colitis and Crohn’s disease.”

Woodcock emphasized that for biosimilars, it is important to her that the FDA applies “rigorous standards” and that while biologics are life-changing and cost-saving, “we don’t intend to sacrifice on their performance with biosimilars.”

Woodcock also placed a bit of blame back on Congress for the slow pace at which biosimilars and biologics are being approved, highlighting the fact that “Congress didn’t appropriate any additional funding to the FDA to implement BPCIA. We took money from other activities.” She did mention that the FDA has begun to collect more money under the user fee program, and that she is hopeful that the FDA will have more “robust funding” for biosimilars. Dr. Woodcock further expressed concern that “as more biosimilar applications come in, … we will not have the staff because we always seem to be waiting to catch up.”