Draft Guidelines are Issued for Biosimilar Products from FDA

The Food drug administration in the draft guidance said, Producers of "biosimilars," should think about using a "stepwise" method of demonstrate their personal product's similarity to at least one that is already in the marketplace.

This process should have a comparison of the planned product as well as the reference product with regard to structure, function, animal toxicity, clinical immunogenicity, human pharmacokinetics and pharmacodynamics, and clinical effectiveness and safety, in accordance with the guidance that is designed to help biosimilar manufacturers navigate the approval procedure for the products.

The document also stated that the organization will additionally examine the “totality of the facts" showing biosimilarity.

The FDA stated the guidance following the Biologic Price Competition and Technology Act of 2009, that's section of the Affordable Care Act. The law sets out the requirements for biosimilarity.

Although the FDA has had the authority to review biosimilar applications since 2010 when the Affordable Care Act became law, it has not yet received any biosimilar applications, Sherman said. However, the agency has received requests for meetings regarding biosimilar variations of 11 drugs currently available, and also has held 21 conferences to date.