Considering safety, effectiveness and cost, are you in favor of switching to biosimilars?
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Click here to read the Cover Story, "Specialists discuss role of biosimilars in future of retinal disease management."
Positive experiences in other areas of medicine are encouraging
Biosimilars are coming and are here to stay.
The patents for bevacizumab and ranibizumab expired in 2019 and 2020, respectively, in the U.S. and in 2022 in Europe. The aflibercept patent may expire in 2023 in the U.S. and in 2025 in Europe. Thus, numerous biosimilars are expected to gain approval, and it is important that our community becomes educated about the defining features of a biosimilar, the differentiation between biosimilars and generics, the biosimilar manufacturing process, the route to FDA approval and the potential impact for our patients.
These complex drugs are conceived to be highly similar to the parent biologic regarding efficacy and safety. There are certainly drawbacks and limitations, such as the smaller clinical trials, the lack of robust safety data and the potential for unwanted enforced step therapy. However, the biosimilar experience in other areas of medicine seems to be positive, and the availability of these agents should lower the cost and increase patient access to on-label anti-VEGF therapy. In retina, we have uniquely had an off-label, inexpensive anti-VEGF option with bevacizumab, but the biosimilars will increase patient access to on-label anti-VEGFs similar to the parent FDA-approved agents.
In the long term, having a cost-effective alternative will allow for research and investment in new technologies, driving innovation and improving on durability and efficacy of the treatment paradigm for age-related macular degeneration and diabetic retinopathy.
Caroline R. Baumal, MD, is a professor of ophthalmology at Tufts Medicine, Boston.
Too many questions are still unanswered
Unlike generic drugs, which are chemically synthesized and identical to the corresponding branded drugs, biosimilars are biologics produced by living cells and are similar — but not identical — to the original reference drug.
While biosimilars undergo clinical trials to demonstrate safety and efficacy, the trials are for a much shorter period (eg, 8 weeks) than for the reference drug, with substantially fewer subjects. Furthermore, there is extrapolation based on scientific justification, such that the trial for the biosimilar can be for any one of the indications for the reference drug, and then the use can be extended once approved to all the indications for the reference drug. There is no need to demonstrate efficacy for all indications as no differences are expected between the biosimilar and originator biologic. However, abbreviated development and limited trials leave the question of whether there will be similar safety and efficacy in the real world once more patients with various genetic, immunologic and systemic comorbidities are treated.
Due in part to the lower cost for development and approval, biosimilars are a more affordable treatment option (15% to 35% lower cost). This may increase access to treatment for patients who otherwise could not afford the reference drug or would have to pay a significant amount out of pocket. Biosimilars have been used in oncology, immunology and diabetology and have shown to be safe and effective while lowering the drug cost and increasing the access to these agents. The twist in ophthalmology is that we already have inexpensive off-label bevacizumab, which has been used for nearly 2 decades with proven safety and efficacy. The acceptance and use of biosimilars by retina specialists remain unclear. Also, many biosimilars are expected to come into ophthalmology. How do we decide which biosimilar to use? How many anti-VEGF agents should we have in the office? Potential mandated use of biosimilars by payers (will different payers require different biosimilars?) and possible step therapy that includes these biosimilars all pose added difficulty for retina specialists. We should be able to choose what is best for our patients and for each eye.
As ophthalmologists, we need to be educated on biosimilars and biologics and exercise post-marketing pharmacovigilance such as online reporting of adverse events to the ASRS Research and Safety in Therapeutics Committee.
Judy E. Kim, MD, is an OSN Retina/Vitreous Board Member.
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