On 2 February 2022, the US Food and Drug Administration (FDA) approved the first generic of Restasis (cyclosporine ophthalmic emulsion).
The newly approved cyclosporine generic is sponsored by Mylan Pharmaceuticals Inc and has been approved as 0.05% single-use vials (eye drops). Restasis is used in the treatment of keratoconjunctivitis sicca, or dry eye, and acts to increase tear production in patients whose tear production is suppressed due to ocular inflammation.
This comes after several years of controversy over Restasis generics. Initially, the originator company Allergen, requested that FDA revise its guidance on cyclosporines, arguing that generic versions of Restasis be tested in humans before approval, not just in a laboratory . Then, in October 2017, a federal judge in Texas invalidated four key patents for Allergen’s Restasis following the originators company’s deal that transferred the patent rights to the Saint Regis Mohawk Tribe [2, 3]. In addition, Israel’s Teva Pharmaceuticals launched unsuccessful lawsuits in the US against FDA over marketing exclusivity of Restasis [4, 5].
Sally Choe, PhD, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said that the ‘approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts’, and that its FDA’s major focus on ‘supporting development and expanding opportunities to bring complex generic drugs to the market’.
The development of complex generics may be more difficult due to, for example, their complex active ingredient formulation or route of delivery. Thus, many complex drugs lack generics competition. The FDA has taken a multifaceted approach to encourage development of complex generics through the Generic Drug User Fee Amendments (GDUFA) program.
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LATIN AMERICAN FORUM
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1. GaBI Online - Generics and Biosimilars Initiative. Allergan objects to Restasis generics being accepted without human trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 25]. Available from: www.gabionline.net/generics/news/Allergan-objects-to-Restasis-generics-being-accepted-without-human-trials
2. GaBI Online - Generics and Biosimilars Initiative. Texan judge invalidates Restasis patents [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 25]. Available from: www.gabionline.net/generics/general/Texan-judge-invalidates-Restasis-patents
3. GaBI Online - Generics and Biosimilars Initiative. US tribal patent deal could prevent generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 25]. Available from: www.gabionline.net/generics/general/US-tribal-patent-deal-could-prevent-generics
4. GaBI Online - Generics and Biosimilars Initiative. US Court rejects Teva’s lawsuit over generic Restasis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 25]. Available from: www.gabionline.net/generics/general/US-Court-rejects-Teva-s-lawsuit-over-generic-Restasis
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