The FDA released new draft guidance Nov. 25 intended to speed up development of biosimilar insulin products and make them more accessible for the millions of Americans who depend on them.
The guidance clarifies the information needed from drugmakers who send in applications for biosimilar insulin products.
It also says that, under certain circumstances, drugmakers do not have to conduct a comparative clinical immunogenicity study — which determines the immune response to the product and its clinical impact — to get approval. The FDA said it generally expects the risk of clinical impact from immunogenicity to be minimal for insulin products that meet the specific conditions.
In addition, as of March 23, 2020, approved new drug applications for biological products will be deemed "biologics license applications" and will be able to be used as a reference product by a drugmaker seeking approval for a proposed biosimilar. The FDA said this could result in more efficient development of biosimilar insulin products and bring them to the market quicker.
Read the full news release here.
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