SEOUL-- Samsung Bioepis Co. diabetes treatment biosimilar received tentative approval from the U.S. Food and Drug Administration (FDA), industry sources said Sunday.
The Lusduna Nexvue developed in cooperation with multinational drug company Merck Sharp and Dohme Corp. (MDS) got the green light because it satisfied all regulatory rules for follow-on biologics of clinical and nonclinical safety, local here observers said.
A biosimilar is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.
The drug, however, is being held back because of the remaining patent period controlled by French pharmaceutical company Sanofi. Resolving the patent issue can take upwards of 30 months.
Samsung had invested funds for the development of the drug with MDS in charge of conducting clinical tests and sales.
Lusduna Nexvue has already been approved in Europe as a biosimilar in January.
Source: Yonhap News Agency