Maligned FDA Deserves Standing Ovation

Oftentimes, we forget how valuable our FDA is because we are used to only seeing the sensational critiques in the media: unwarranted drug approvals, inadequate surveillance, negligent public alerts or inappropriate industry influence. Yet, there are moments to celebrate the FDA, as well. Under  great pressure, last week, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) released a much awaited and much needed draft guidance for industry, entitled, “Nonproprietary Naming of Biological Products and also a Proposed Rule: Designation of Official Names and Proper Names for Certain Biological Products.” The draft guidance details how “certain biological products,” more commonly known as biosimilars, will be given distinctive names from their reference product, essentially signposting their recognition that unique names protect patient safety. [[{"type":"media","view_mode":"media_crop","fid":"41003","attributes":{"alt":"Steve Marmaras is manager of state and national advocacy for the Global Healthy Living Foundation","class":"media-image media-image-right","id":"media_crop_8838991122320","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4260","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.0080003738403px; line-height: 1.538em; float: right;","title":"Steve Marmaras is manager of state and national advocacy for the Global Healthy Living Foundation","typeof":"foaf:Image"}}]]

Matching Medicines and Patients

Complex biologics, whether infused or injected, have been life-changing for patients living with autoimmune diseases and the rheumatologists and other specialists managing ever expanding patient populations.  However, these drugs are not perfect. For many patients, high costs and complicated insurance policies limit their access. But more troubling, many of the autoimmune patients who rely on biologics find that, over time, their bodies adapt to the treatment and, then, effectiveness wanes. This inevitably leads to patients cycling through all available treatments and running out of options.  Enter a new class of cutting-edge products called biosimilars, designed to mimic reference biologics. Scientifically, they are similar to but not exactly the same as their reference biologics. Think of them as snowflakes. The FDA began to consider how to approve biosimilars in 2010 after the Biologicals Price Competition and Innovation Act (BPCIA) became law under the Affordable Care Act. The BPCIA Act essentially created a shortcut licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product. Biosimilars appealed to the FDA, industry and patients, alike, because the new medicine class might expand treatment options and reduce costs, a result already seen in Europe where biosimilars hit the market about five years ago.  Despite the existence of the BPCIA, it did not answer key questions about biosimilar approvals and the FDA has been

highly criticized

recently for not finalizing its policies, namely on how medicines in this new medication class will be named, evaluated for interchangeability and if indication labeling (efficacy) can be extrapolated compared to the reference biologic. The first biosimilar only earned approval this past March – filgrastim-sndz, Zarxio. It has a distinct name (which possibly will change, now) but was not approved as interchangeable to its reference biologic, Neupogen. The FDA may have taken its time to evaluate all available data and listen to the diverse perspectives of the multitudes of stakeholders involved in regards to biosimilar naming, but the Global Healthy Living Foundation, parent non-profit to the popular patient community CreakyJoints,  believes that the new guidance regarding biosimilar naming hits the mark. The proposed guidance requires biological products licensed under the Public Health Service Act (PHS Act) have unique names that include a FDA-designated suffix composed of four lowercase letters. This will apply to previously licensed products such as biologics as well as newly approved biosimilars. The nonproprietary name of originator biologics and their biosimilars will include a unique suffix. In a 2012 Alliance for Safe Biologic Medicines survey of 376 specialist physicians, 76 percent reported that if two products share the same non-proprietary scientific name it suggests or implies the products are identical structurally. Eighty-six percent of physicians surveyed indicated that they report adverse events by product name rather than a National Drug Code (NDC) number. So the FDA guidance allows

physicians

to exhale in relief as well.  The FDA draft guidance will allow for physicians to easily differentiate the reference biologic from the biosimilar and one biosimilar from another from a different manufacturer.  Major Win For Patients and PhysiciansThis proposal marks a major win for patients and physicians, a giant step forward in ensuring patient safety, and establishing confidence in a promising class of life-changing medication.  Patient Safety First At the Global Healthy Living Foundation, and within the patient community CreakyJoints, we believe distinguishable names are essential for patients and physicians for five reasons: 

• Biosimilars are not a new kind of generic medication:  Because biologic medicines are very complex and very sensitive, they are nearly impossible to replicate. Every biosimilar will vary from the reference biologic and each other.
• To protect patient safety:  Distinguishable names mean patients and physicians can clearly identify medications. If a patient experiences an adverse event, side effect, or change in condition, the exact prescribed medicine is easily identifiable
• To minimize confusion:  In the event of a drug recall, for example, unique names ensure timely detection, assessment, and prevention of any adverse effects from a product, or even a batch of products. 
• To increase transparency:  Once biosimilars are approved by the FDA, it is up to the individual states to determine access. New laws are required to protect patients from substitution of a biosimilar for a prescribed biologic without appropriate notification of the patient and/or physician. This year alone, states including Utah, Colorado, Washington, Louisiana, North Carolina, Georgia and Texas (and others) passed legislation requiring pharmacists provide notification in the event of an insurance company-originated medication switch. Distinguishable names are important to alert patients to switches should such laws not be in place.
• To help manage costs:  Biosimilars should have unique names and, by extension, distinct reimbursement codes to avoid confusion among providers and dispensers and to help create a viable market for biosimilars in the United States. 

Steve Marmaras is the manager of state and national advocacy for the Global Healthy Living Foundation, a 501(c)(3) non-profit organization, based in Upper Nyack, New York, with the mission to improve the quality of life for people with chronic illness.

GHLF advocates for improved access to care at the community level, amplifying education and awareness efforts within its social media framework. Central to this advocacy are GHLF’s successes educating about the importance of diagnosis, early and innovative medical intervention, long-term lifestyle improvement with the goal of improved outcomes

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