By Brian Bamberger, Life Sciences Practice Lead
Biosimilars are officially approved subsequent versions of off-patent biopharmaceutical products, sometimes also called ‘follow-ons.’ Like the biologics they’re following, these ‘large molecule’ drugs are made from living organisms and used to treat complex diseases, including Alzheimer’s and cancer. Examples of biologics include gene therapies, blood or blood components, vaccines, allergenics or recombinant therapeutic proteins.
Already in use in Europe, biosimilars are poised to enter the US market in 2015, with two such drugs already in the Food and Drug Administration’s (FDA) approval pipeline.
Paving the way for their introduction was the Biologics Price Competition and Innovation Act passed in 2009. Market entry has been slow for many reasons, not the least of which is the challenge of integrating biosimilars into the current US drug supply, order, distribution and administration system.
Perhaps one of the biggest challenges is that biosimilars are not generics, which are FDA-defined bioequivalents of small molecule (traditional) drugs synthesized using chemical processes. Unlike generics, biosimilars are not integrated with pharmacy inventory and dispensing, ePrescribing, claims switching – all core infrastructure components built for pharmaceuticals marketed by chemical name and bioequivalent to a brand/reference drug product.
Biosimilars, on the other hand, are manufactured in or from biological sources and not always interchangeable, identical or bioequivalent. In fact, the FDA will give them four ratings:1) not similar, 2) similar, 3) highly similar, and 4) highly similar with a fingerprint-like similarity. Clarity will be provided in thePurple Book, which is meant to be the equivalent for biologics profiled in the Orange Book, a statutorily required, FDA publication that links small-molecule drugs to approved therapeutic equivalents.
Regardless of the rating, biosimilars may perform very differently from the original branded version, thus posing a safety concern.
Whereas the chemical process used to synthesize small molecule generics is relatively straight-forward, that’s not necessarily the case with large molecule biologics. One of the challenges with biosimilars is that their manufacturers do not have access to the innovator product’s original molecular clone or cell bank, nor to the exact manufacturing processes or active drug substances. Furthermore, there are concerns that even within the same manufacturer, there may be variations by lot. All of this leads to the importance of tracking by manufacturer and lot number.
Like small molecule medications, prescriptions for biologics and biosimilars are written by physicians. Unlike traditional medications, biologics and biosimilars are dispensed via channels that are more limited and controlled, which makes them theoretically easier to track. However, they may be administered in a variety of clinical settings, or self-administered by the patient him or herself.Today the drug, manufacturer and lot numbers rarely reach the point of administration, making it a challenge to record specifically what was administered, particularly for cases of patient self-administration.
Further confounding the situation is that information about the administered biologic does not get communicated back to the prescribing physician. The reason is that there is no consensus on the rationale for doing so, and the supporting transactions either do not exist, are not being used or have yet to be standardized.
This is important because adverse events are most commonly reported by the patient to their physician. Without the knowledge of what biologic or biosimilar was dispensed, linking the adverse event to the manufacturer, drug and lot number is a real challenge and a missed opportunity.
It is suboptimal because, ideally, an adverse drug event would be traced back to the manufacturer, drug and lot number of the administered biologic or biosimilar, ensuring that impacted patients are alerted and situation addressed more efficiently. In addition, it would provide data to help justify non-impacted patients remaining on therapy, and provide critical information to the manufacturer and Federal government that will help address potential future challenges and decrease risks.
This is where electronic health records and health information technology can help. We will address these benefits and the potential high value of biosimilars in a future article.