FDA Approves Biosimilar Drug for Treating Macular Degeneration

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The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). The drug is Byooviz (ranibizumab-nuna), a biosimilar to Genentech's Lucentis®, and like Lucentis® has been approved for treating several eye diseases and conditions. Specifically, according to the FDA announcement, Byooviz is approved for "neovascular (wet) age-related macular degeneration (nAMD)[,] macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness)." In the announcement, Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research (CDER) was quoted as saying:

Today's approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products. Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.

For those keeping score, this is the 31st biosimilar product approved by the FDA (and the last one, Semglee (insulin glargine-yfgn), was the first approved interchangeable product). The details regarding these approved products are set forth in this table:

Table

It is certainly the case that the pace of these approvals is not what their proponents envisioned or expected, and that has led to some frustration (never a good thing when it is experienced by impatient policy makers; see, e.g., "A Solution in Search of a Problem"). Nevertheless, the pace of agency approvals is increasing, despite some slowdown due to the COVID-19 pandemic, and all signs indicate that it will increase (see, e.g., Biosimilars Council, New Analyses Point to Opportunities to Increase Savings from Biosimilar Adoption). Which seems to be what everyone wants.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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