Helpful Hints for Use of Biosimilars in Ophthalmology Practices

Peter Kaiser, MD: When it comes to biosimilars, it’s important for an ophthalmologist to look very closely at the clinical studies to understand the approval process and to understand what a biosimilar is. Now, it goes without saying that the first biosimilar to be FDA approved came in at a list price considerably lower than reference ranibizumab, so this is a good thing for the health care system, and it remains to be seen what the pricing [will be] of the additional biosimilars that are currently in front of the FDA. In terms of concerns with using the biosimilar, the FDA does a good job testing the analytics of these medications and the clinical studies show us that the safety and efficacy, at least in a 1-year time point, is very similar. From my standpoint, I do not have any hesitation using a biosimilar. I will, of course, watch the patients closely and these companies are having postmarketing pharmacovigilance to look for anything that may not have come out in the clinical studies, but right now, I don’t have any overt concerns.

When we look at biosimilars, this is a new treatment that we need to put into our refrigerators. We have to decide which patients we may use a biosimilar on, which patients we may use a reference product on, and which patients we have to use a totally different anti-VEGF medication. These are all things that we are going to work out over time. Thankfully, we know the pricing of the first ranibizumab biosimilar to be FDA approved and it’s considerably lower than the reference product. But it’s important for anyone considering the use of biosimilars to look at the reimbursement, understand what this means for their particular situation and their particular practice, and understand some of the patients’ assistance programs, etc, that are being put into place by companies selling biosimilars. But you may need to make sure that your patients, their payer mix, and their insurance coverage is all answered before you use this, but suffice it to say, that just like reference ranibizumab, all of those programs that you were used to having are being put into place by the companies marketing and selling the biosimilars of ranibizumab.

When you talk to patients about the use of biosimilars, patients at this point in life have become used to the idea of biosimilars. The reason I say that is because they are so used to generics and although biosimilars are not a generic (I don’t want my audience to get confused by that), the fact of the matter is, that even when I go to a pharmacy, I am always asking for the generic version of the medication because I know that the FDA has shown the similarity and has FDA approved it, so I’d rather pay less. Patients are similarly going to accept biosimilars since they understand how expensive it is and they are always asking if there is any way to reduce pricing and this is really one way. It is up to us as ophthalmologists to explain to the patients about the approval process and to explain the safety and efficacy that was shown in clinical studies, but at the end of the day, patients will accept biosimilars. In fact, of all the cogs in the health care system, both the insurance companies and the patients are the ones who are most apt to accept it. It is up to the physicians to be the conduit of information for their patients.

Transcript edited for clarity