Biosimilar Saftey and the Real Patient Voice

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  • 07/17/2014

Desperate too-clever-by-half efforts to derail biosimilar pharmacovigilance are contrary to the public health and require rebuttal.

Some generics manufacturers, payers, and national chain drug stores have interwoven half-truths, out of context comments and just plain misinformation to build a fatuous argument dressed up as support for patient safety. But the actual patient and safety communities are firmly on the polar opposite side – in favor of safety, choice, and transparency.

The insurance-industry driven effort claims that distinguishable names for biologics “could lead to patient and prescriber confusion, increasing the possibility of medication errors.”  Unpacking that a bit, biologics are complex therapies that are made from living cells and prescribed for patients with difficult-to-target, debilitating and life-threatening health conditions such as cancer, diabetes, MS, lupus, Crohn’s disease and rheumatoid arthritis. There are no generics for them but it is expected that the closest thing –  biosimilars – will soon enter the US marketplace. What the insurers are essentially saying is that, a biosimilar that relates to a biologic should have exactly the same name as that biologic. 

In the case of biologics and biosimilars, even minute differences between products can cause individual patients to respond differently even though each product is considered safe and effective. Of greatest concern is immunogenicity, which carries a significant risk for all biologics. Because of the size and complexity of the biologic molecule, patients can experience unwanted immune reactions; these reactions can occur months after a patient begins taking the medicine and it is often difficult to know if it is due to the reaction to the medicine or simply the progression of the patient’s condition.

With all of these considerations, it stands to reason that the name of biologics and biosimilars should be similar, not the same. But rather than taking my word for it, consider these important viewpoints:

Distinguishable names…will enable the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for minorities. This will lessen the inevitable confusion and assure optimum medical care in the use of biosimilars among minority populations.” – From a June 10th letter to FDA signed by 22 of the leading U.S. organizations focused on minority health, including the National Alliance for Hispanic Health, National Hispanic Medical Association and National Medical Association.

“…For millions of female patients, any potential increase or decrease in effectiveness of a biologic, along with side effects and adverse reactions, will only be discovered after the treatment is approved and under active use…As states across the country look to the FDA for guidance on issues surrounding biosimilarity, interchangeability, and therapeutic substitution, the agency’s views on sex and genomic-based differences will be crucial…Distinguishable names will enable the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for both men and women.” – From a May 20th letter to FDA spearheaded by the Society for Women’s Health Research and signed by 45 other leading U.S. organizations focused on women’s health.

Distinguishable names for biologics support the medical community’s vital post-approval learning curve about which medicines are best for their rare disease patients. Health care providers need to know that a prescribed medicine was actually given to the patient and whether a substitution was made and to what alternative product. This can’t be achieved unless biologic products—especially ones with similar therapeutic purposes—cannot be distinguished, tracked and studied.” – From a June 3rd letter to FDA by the National Organization for Rare Disorders (NORD), the umbrella organization representing the interests of the many advocacy groups that serve 30 million patients impacted by nearly 7,000 rare diseases.

By my estimate, the patient-focused organizations that have come out in support of distinguishable naming cover just about every single American family. Fully addressing all of the inaccuracies and agenda-driven language in the insurance-industry driven letter requires an extensive point-by-point rebuttal [link to one], but the key take-away is this:  if you’re for patient safety, you can’t be against distinguishable naming.

As acknowledged by WHO and regulatory bodies of every developed nation, biologics are not chemical compounds (e.g., statins) — they’re infinitely more complicated. When it comes to biosimilars, we need to be extremely thoughtful about how we set policy and strike a balance that promotes health and safety, rather than forcing a binary response that is driven by profits rather than patients.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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