Biosimilars
With the more common small-molecule drugs, an exactly identical generic drug can be reliably produced and marketed. Because biologics are vastly more complex, other manufacturers cannot guarantee that their version is exactly identical to the original manufacturer's version, although it is similar to the original biologic. The subsequent manufacturer may use a slightly different manufacturing process, which can occasionally produce significantly different effects. The follow-on manufacturer does not have access to the originator's molecular clone bank and original cell bank. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications.
Because different manufacturers may produce slightly different products, they consequently cannot guarantee that their version is exactly as safe and effective as the original manufacturer's version. So, unlike most drugs, generic versions of biologics were not authorized in the United States or the European Union through the simplified procedures allowed for small-molecule generics. As a result, nearly all biologics have been brand-name therapeutics and required very extensive testing. Notable exceptions to this rule include several of the earliest biopharmaceuticals made via recombinant DNA technology, including biosynthetic 'human' insulin and human growth hormone.
Legislation in the 21st century has attempted to address this by recognizing an intermediate ground of testing, which is more testing than for small-molecule drugs proven to be identical to each other, but less testing than for completely new therapeutics.
In the European Union a specially adapted approval procedure has been authorized for certain protein drugs, termed similar biological medicinal products. This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product.
Within the U.S., the Patient Protection and Affordable Care Act of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA licensed reference biological product.
The acceptance of biosimilars may reduce the profitability of biologics and the cost to the patients and healthcare systems.
Read more about this topic: Biologic Medical Product