Biosimilars are biologically but also in clinical practice for all intents and purposes identical to the original drug, as has been shown in blinded trials. But the perception amongst patients and sometimes physicians is one of possible inferiority, therefore they are often reluctant to transition to a biosimilar. However, although the listed prices of biosimilars and original products are the same, discounts are often higher for biosimilars, and widespread adoption of biosimilars drives the mean discount opt. So, society, hospitals, insurance companies and governments have preference for introduction of biosimilars to drive costs down.
Starting in new patients with a biosimilar is not controversial. Transitioning existing users from originator to biosimilar however is. This field has some interesting aspects, two of which will be elaborated on:
1/ balance of power, interests and ethics: different approaches are used by hospitals, insurance companies and governments to get biosimilars in use (collective buy e.g.). Big pharma are sometimes using campaigns to discredit biosimilars (create FUD, Fear Uncertainty and Doubt) towards patients and doctors, although some pharmaceutical companies are making original biologicals as well as biosimilars. Scientific societies of doctors have different recommendations, based on different beliefs towards biosimilars. In Most countries, Patients freedom of choice and right for best care are seen as paramount, but the other side of the coin might be that patients can be asked to adhere to a “social contract” to help in making healthcare financially sustainable for all.
2/ nocebo and attribution in open label transitioning: blinded research has shown that tansitioning to a biosimilar is not different with regard to safety and effect than continuing the original biological. However, in clinical practice a patient and physician knows that the patient has changed to a biosimilar. This may lead to nocebo effects (due to the perceived inferiority of the drug, experiences of subjective adverse effects and loss of efficacy are induced). In addition, adverse events of loss of efficacy that occurs independent of drug switch might be attributed to the biosimilar, called incorrect causal attribution. Both effects lead to more patient stopping a biosimilar after unblinded switch than in blinded studies. Prevention of nocebo and attribution in daily care is perhaps possible using a variety of techniques (e.g. restriction of fall back to originator, n=1 blinded provocation test, biobetter communication, patient incentive, patient/physician education), but this requires more research.
In summary, the use of biosimilars is a chance for society to maintain healthcare affordable, but it represents a challenge to maximise this potential.
Disclosure of Interest None declared
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