Based on an announcement last week, the longtime generics manufacturer Lannett would become among the first to file for insulin glargine product approval under the 351(k) Biologics License Application pathway.
Venable’s Ha Kung Wong discusses previous and future approval processes for insulin biosimilars, including clinical testing and the possibility of receiving an interchangeability designation.
Read the full article here.
Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.
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