On June 15, 2020, Ha Kung Wong was quoted in the Center for Biosimilars discussing Lannett’s insulin glargine biosimilar candidate. According to the article, the longtime generics manufacturer would become among the first to file for insulin glargine product approval under the 351(k) Biologics License Application pathway.
Insulin products have previously tended to be approved under the 505(b)(2) pathway, under which applicants have had to do clinical studies to gain approval. Two phase 3 studies were done for Basalgar, Wong noted. So it will be interesting to see whether the clinical testing requirements for Lannett’s insulin glargine candidate under 351(k) are as rigorous or less so, he said.
It will also be interesting to see whether or how easily Lannett’s insulin glargine obtains “interchangeable status,” which would mean pharmacists could decide on their own whether to fill prescriptions with this or Lantus. Much depends on the extent FDA’s interchangeability standards actually differ under the 351(k) pathway in practice for follow-on insulin products versus for other biosimilars, Wong said.
“Interchangeability status will give the follow-on insulin automatic substitution, depending on the state, at the pharmacy level, something that follow-on insulin via the 505(b)(2) pathway did not have access to. However, we know that interchangeability status typically requires additional testing,” he said.
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