Viatris has received the US Food and Drug Administration (FDA) approval for the first generic version of Abbvie’s dry-eye drug Restasis (cyclosporine ophthalmic emulsion).
Restasis is a commonly prescribed immunomodulator that works to increase tear production in patients with keratoconjunctivitis sicca, commonly called dry eye.
The disease occurs when a patient’s eyes fail to produce adequate tears to keep them wet or produce tears with improper consistency.
Patients currently taking topical anti-inflammatory drugs or punctal plugs are not experiencing improvement in their tear production, said FDA.
FDA Centre for Drug Evaluation and Research Office of Generic Drugs director Sally Choe said: “Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes.
“Today’s 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.
“Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices.”
Viatris was formed in 2020, through the merger of generic and speciality pharmaceuticals firm Mylan with Pfizer’s legacy business unit Upjohn.
AbbVie has obtained rights to Restasis, as part of its $63bn takeover of Allergan in 2020.
In 2017, Allergan licensed the drug’s patent rights to a Native American tribe in push to protect the drug from generic competition.
Restasis has generated $1.29bn in revenues for AbbVie last year, increased by 64% from the previous year, and is expected to make $655.6m this year, reported Reuters.
FDA said that it has taken a multifaceted approach to endorse the development of complex generics through its Generic Drug User Fee Amendments (GDUFA) programme.
The US agency has been carrying out research to support the development of cyclosporine ophthalmic emulsion, under its GDUFA Science and Research Programme.
It has supported 16 research projects related to cyclosporine ophthalmic emulsion to date, claimed the US FDA.
