GSK Korea is facing competition from DongKoo Bio&Pharma for its exclusive chronic hand eczema market share, as the latter has received sales approval for a generic version of Alitoc. The Korean company obtained sales approval from the Ministry of Food and Drug Safety on Tuesday.
|GSK Korea's chronic hand eczema treatment Alitoc|
With the approval, DongKoo has come one step closer to obtaining priority sales right for its generic product.
Alitoc is the world’s first drug that had indications for recurrent chronic severe hand eczema in adults who do not respond to strong topical steroid treatment for at least four weeks.
The drug is a retinoid-based vitamin A derivative involved in the growth and differentiation of keratinocytes and reports retinoid receptors that bind both retinoic acid receptors and retinoid X receptor nuclear receptors. It is also the only oral chronic eczema treatment
It has excellent anti-inflammatory, immunomodulatory, epithelial cell differentiation effect, and has a low recurrence rate. The drug is also convenient for patients as they only need to take one pill a day.
As GSK received reimbursement for Alitoc in 2015, local prescription has surged, and Korean drugmakers started developing a generic version of the drug.
Pharmaceutical companies that started developing the products began to file for invalidation trials to nullify the composition patent and succeeded in obtaining a ruling in their favor last year. As a result, pharmaceutical companies, including DongKoo, applied for priority sales right.
The preferential sales right is a system that allows a pharmaceutical company that wants to manufacture and produce a generic version of a drug to preemptively market its product for nine months if it wins a patent trial against the original drug holder.
If the priority sales right is granted, the company can start selling its generic in the market without competing with other pharmaceutical companies for nine months from Nov. 19.