There are many examples of efforts to make biosimilar products, such as every time a product is taken to a larger
scale, and when an established product is transferred to another facility, including a contract manufacturing site.
While most of these examples have resulted in products which were indistinguishable for all practical purposes,
others revealed troubling differences during product characterization or clinical administration…
Tag: <span>biogenerics</span>
Several developing countries, including India and China, have young biopharmaceutical industries that have based much of their growth potential on the production of what are currently known as “biogeneric” products, or “bioequivalent” versions of biologics that have already been licensed in Western countries. With a disdain for foreign patents, an established philosophy of copying Western innovations, and success in generic pharmaceutical manufacturing, this approach appeared to be the logical way to build a biologic manufacturing industry. However, there are numerous problems with this development strategy. First and foremost is the inherent incompatability of the very concepts associated with biogeneric products…