Reference no: EM132738192

"After years of debate, the US Food and Drug Administration (FDA) is poised to allow the sale of biosimilars, cheaper versions of complex and expensive biological drugs used to treat conditions such as cancer and autoimmune diseases. On 7 January, an FDA advisory panel decided unanimously that a drug made by Sandoz, the generics arm of Swiss pharmaceutical giant Novartis, should be accepted as a replacement for filgrastim (Neupogen), an immune-boosting protein drug for people undergoing cancer treatment made by Amgen of Thousand Oaks, California. Such knock-offs are called biosimilars because the drugs that they mimic, dubbed biologics, consist of complicated molecules that are made in living cells and are impossible to copy exactly. Even copying them inexactly is immensely challenging - despite the expected approval of the Sandoz drug, the difficulties involved in creating and evaluating biosimilars may limit their infiltration of the marketplace. The field is also littered with patent issues, especially with regard to how the drug is manufactured. In the case of filgrastim, Sandoz is challenging some of the legal requirements for approval."

Describe a plausible biotechnology that enables the production of filgrastim as a drug in a large scale and How do the patents of Filgrastim make the development and manufacturing of its biosimilars extremely challenging? Describe the nature of the patents and their major roles in biotechnology.