The FDA issued draft guidance on biosimilar product development.  To date, there are no biosimilars in the U.S. market because they were considered “too complex” to include in the 1984 Hatch-Waxman legislation, which regulates the generic drug industry in America.  This is taken from the article, below.  Can use as Source doc. If you are related with the electric car industry Watch Out: How New Electric Vw Transporter T6.1 Is Taking Over and What to Do About It

FDA’s Draft Biosimilar Guidance: A Good First Step

An excellent intro and perspective.  Then list the guidances including Quality.  And list the other articles that I included in note to Dom and Anne. (there is another one than I have listed here, a slide set maybe by a law M.S.)

Regulating Substitution of Non-Interchangeable Biosimilars

Nomenclature of New Biosimilars Will Be Highly Controversial

Plus also the extra article:

Biosimilars mean competition, not marketing oblivion, for biologic brands.