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Dr. Michael Klufas

3yr
Biosimilars in Ocular Indications

Biologics are naturally sourced molecules engineered to target specific pathways in many inflammatory and autoimmune disorders. In the last decade, there has been an increased interest in the development of biologics in the treatment of inflammatory diseases (typically but not always rheumatologic conditions). Anti-VEGFs, given intravitreally, are increasingly being utilized in ocular indications including age-related macular degeneration and diabetic retinopathy. These biologics have significant clinical benefits, including gain of vision, but may come at a high financial cost. Importantly, the emergence of biosimilars is expected to play a key role in lowering healthcare costs and improving patient access. As a step towards improved patient access and decreased burden to the healthcare sector, the EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines approved in the EU are interchangeable not only with their reference medicine, but also with an equivalent biosimilar. In 2022, the FDA has also shown a positive stance towards biosimilar approvals with recent biosimilars being approved without ‘switching’ studies.

What are your perceptions of the efficacy and safety of ocular biosimilars? What are the barriers or challenges faced by biosimilars and their uptake?

  • 3yr
    It seems the main advantage would be price. While this seems beneficial on the surface, most of the patients needing these treatments are of Medicare age and therefore would not see any benefit. I think MD's using these biosimilars are not going to use what is the cheapest, but works most effectively. Without further studies to show similar efficacy, I don't see them taking off.
  • 3yr
    My perception is that they are safe. The challenge is how to make it more accessible and cut down cost.
  • 3yr
    Too often we are forced by payers to select a preferred product. In the case of biosimilar agents, individual patient response will vary. Collectively a large amount of time will be expended in this effort. Some patients will suffer with less than ideal results.
  • 3yr

    Most of us will not prescribe a bio similar unless we are forced to thru insurance or ACO mandates.
    If side effects are higher than originator molecules their utilization will plummet.
    Fortunately the companies making our biosimilars are well respected.

  • 3yr
    I have posted previously about the cost benefit of biosimilars. But I am very concerned about the immunogenicity, and purification of biosimilars for intravitreal injection. The clinical studies that I have seen for Byooviz have had woefully few participants, whereas Lucentis has the longest history of intravitreal use of any of the anti-VEGFs. Does anyone else have any reservations on the intravitreal use of biosimilars?
  • 3yr
    The stated goal of the FDA is to grow the number of biosimilars approved as a means of providing greater access to treatment options for patients, encourage more competition, and potentially lower costs. Of course this has merit, but i think it is disappointing that the ONLY benefit of an ocular biosimilar, or any biosimilar, in general, is one of lower price. Biosimilars will certainly be enthusiastically embraced by insurance providers, but probably not to any large extent by retinal physicians, as they do not offer any improvement, other than cost. Byooviz offers comparable efficacy and safety as Lucentis, with a significantly lower cost. I can see where this will definitely be of value with self-pay patients receiving treatment. But as it does not offer any improvement in efficacy, or any elongation of the time interval for treatment, I doubt that biosimilars will have much of an impact on our treatment preferences in the long term.

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