Meningitis outbreak should guide FDA action on biosimilars

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Currently the FDA is drafting policies to regulate biosimilars – copies of complex, large-molecule, biologic drugs. According to the FDA, these medicines “can be composed of sugars, protein, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues [and] are made from a variety of natural resources – human, animal, and microorganism – and may be produced by biotechnology methods.” Current examples of these medicines are monoclonal antibodies for cancer treatment and drugs that modulate the immune system to treat rheumatoid arthritis, multiple sclerosis, and psoriasis. The difference between biologics and conventional medicines is that the latter are made from chemicals and have known structures, whereas biologics and biosimilars tend to be heat-sensitive, can become easily contaminated by microbes and small changes in their structures can lead to unexpected or even harmful effects in patients.

Because of their volatility, and the need for the public health system to be able to identify and respond to manufacturing errors – like tainted steroid injections that led to the meningitis outbreak – a comprehensive track and trace system must be in place for biosimilars.
 
On its website the FDA advises that adverse events related to biologics be reported via the FDA’s MedWatch program or contact the Vaccine Adverse Event Reporting System (VAERS) for vaccines. However, with many biological medicines coming off-patent in the following years and being copied by generic drug companies, additional measures must be included. There are also currently no procedures in place to distinguish between a biologic medicine and its biosimilar(s), which are similar but never identical. And with biologics and biosimilars, adverse reactions from these products are often seen only weeks or months later, complicating tracking and tracing measures.
 
To protect patients, the FDA should require unique product names, labels and product codes, as well as a system to distinguish between a biologic and its biosimilar(s) and track and trace all products. This is very important because according to a recent survey conducted by the Alliance for Safe Biologic Medicines (ASBM), “the vast majority (99%) of physicians refer to biological medicines by name for both recording in charts and for reporting adverse events...”
 
Additionally, and very importantly, doctors and their patients should decide what biologic medicine a patient receives, and this decision can never be overridden by a pharmacist or insurance company. Eighty-five percent of responding physicians to the ASBM survey support this position. Finally, the FDA must ensure that robust clinical testing is performed on all biologic and biosimilar medicines to guarantee the same safety, purity, and potency. If not properly regulated, patients could be placed in unnecessary danger. The silver lining of the Senate HELP hearing is that we still have time to protect patients against future adverse events.
 
Petersen is currently director of the Breast Surgery Clinic of St. Barnabas Hospital in the Bronx, New York and adjunct associate professor of Surgery at New York University School of Medicine.


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