Maui Derm 2016 Highlights: Concerns for Using Biosimilars in Daily Practice

J. Wu, MD

Are we following “first, do no harm”? Dr. Wu explained that non-medical switching of patients from originator products is already happening and it is affecting patients. Results from patients followed in Europe have indicated that patients with forced non-medical switches to biosimilars have more hospitalizations and emergency department and physician visits than patients continued on the originator product.

Extensive post-approval pharmacovigilance is required for biosimilars since short-term trials and small patient samples may result in failure to detect rare, but clinically important, adverse events.

Some experts support the view that a biosimilar is just “another lot” of the originator product, but much remains to be learned before this can be stated with confidence.

Maui Derm 2016 Highlights: Pre-clinical Characterization of Biosimilars

A. Blauvelt, MD

Before you consider a potentially less-expensive option, you need to understand exactly what you’re getting. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. The wiggle room in the definition of these agents is in terms such as “highly similar” and “clinically meaningful”. What do they actually mean?

The pathway to approval for a biosimilar is very different from that of the originator molecule. Biosimilar development is focused on preclinical evaluation while that for the originator is concentrated on clinical trials.

Biosimilars are reverse engineered from the originator amino acid sequence to derive the DNA sequence. Biosimilars are identical to the originator for amino acid sequence, but that is all. Glycosylation (addition of sugars), protein folding, and other characteristics may be different. Glycosylation is critical since it is a key determinant of protein function and immunogenicity. Is there a risk associated with this? Time will tell.

Manufacturers want the “fingerprint” of the biosimilar to be as close as possible to the originator agent, but there is no criterion for close the match must be. There is a significant “degree of residual uncertainty” about biosimilars. Higher uncertainty will lead to a requirement for more supporting clinical data.

Maui Derm 2016 Highlights: Pharmaceutical Counterfeits – Are They in Your Practice or in Patient Hands?

M. Gold, MD

Dr. Michael Gold explained the grim reality – There continues to be a huge global marketplace for fake toxins, fillers, and similar aesthetic products promising efficacy at cheap prices. Fraught with innumerable safety risks, and derived from uncontrolled and dubious production methods, many of these fake products contain toxic or at best utterly inert substances. These knockoffs can come in very realistic looking packages and are often “supported” by fake PI’s, websites, and seemingly legitimate journal references that turn out to be phony. The cheap products come from Eastern Europe and Asia. We should make sure our orders are direct from pharmaceutical companies and/or known, established and regulated distributors. Are we doing enough to educate patients and consumers who can easily find and buy these dangerous bogus products online?

New Toxins Coming
Ipsen, Galderma, and Alphaeon all have new neuromodulating toxins in later stages of development. While this provides more options with efficacy apparently similar to current modalities, it may create more confusion. We’ll stay tuned to monitor which is the best for our particular patient needs.

Filler Complications – Could You Cause Blindness?
The risk of blindness due to poorly placed injections has been well described and documented in literature. Consider carefully the underlying vasculature and anatomy (and the many variations and anomalies thereof) when using neuromodulators and fillers. Train staff to screen for and avoid causing an otherwise avoidable complication. Your practice should have protocols and supplies on hand to deal with complications expeditiously.