Skyrizi biosimilar launch date?

When Can We Expect Skyrizi Biosimilar Launch Date?

Skyrizi, a medication for treating psoriasis and other autoimmune diseases, has gained significant attention in the pharmaceutical industry. Developed by AbbVie, Skyrizi is a human monoclonal antibody targeting interleukin-23 (IL-23). As of now, there are no approved biosimilars for Skyrizi available in the market.

Who is Challenging the Patent?

Companies like Mylan, Pfizer, and Eli Lilly are likely to challenge the Skyrizi patent as the patent expires. DrugPatentWatch.com tracks patent information and predicts when patents will expire [1].

How Long Does Exclusivity Last?

The Skyrizi patent for AbbVie was set to expire in 2029 in the United States under the US Biologics Price Competition and Innovation Act. However, exclusivity may be extended or modified due to regulatory actions or litigation [2].

Biosimilar Launch Timeline

It's unlikely that a Skyrizi biosimilar will be launched before 2029 in the United States, as the patent is set to expire. However, biosimilar launch timelines can vary depending on FDA approval, patent litigation, and marketing authorization decisions.

When Does Exclusivity Expire?

While the Skyrizi patent for AbbVie expires in 2029, it's essential to monitor the US FDA website for regulatory updates and modifications to the exclusivity period [3].

References:

[1] DrugPatentWatch.com. (n.d.). Skyrizi (risankizumab) Patent Expiration Dates. Retrieved from https://www.drugpatentwatch.com/patentexpiration?drugname=risankizumab&search_form=submit

[2] U.S. Food and Drug Administration. (n.d.). 2023 PDUFA Date Schedule. Retrieved from https://www.fda.gov/drugs/new-drugs-fda-cders-new-drug-application-nnda/2023-pdufa-date-schedule

[3] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/