4 ms·
Actually, it won't be so easy. Avastin is a biologic drug, so it's not possible for generic manufacturers to produce an exactly equivalent product. Eventually,
by shoyer 13y ago
Actually, it won't be so easy. Avastin is a biologic drug, so it's not possible for generic manufacturers to produce an exactly equivalent product.
Eventually, generic manufacturers may be able to compete (the generic clones of biologic drugs are called biosimilars), but it will take a long time and significant resources, because they will need to run new clinical trials to show that the new drugs are equivalent:
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.
http://en.wikipedia.org/wiki/Biologic_medical_product#Biosimilars http://en.wikipedia.org/wiki/Biologic_medical_product#Biosim...
The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010 - none have yet been approved.
http://en.wikipedia.org/wiki/Biosimilar#Approval_processes http://en.wikipedia.org/wiki/Biosimilar#Approval_processes
- varelse 13y agoReally? http://www.biopharma-reporter.com/Markets-Regulations/Dr-Reddy-s-looks-to-bring-biosimilars-to-EU-within-five-years http://www.biopharma-reporter.com/Markets-Regulations/Dr-Red... Because at $75M to $250M a pop, they're way cheaper than developing a new Biologic ($1B-$2B) and that's because while none have been approved yet, the pathway in the Patient Protection and Affordable Care Act is shorter than that for a new Biologic. I think Big Pharma will do what it takes to make this happen myself. Just like Google will apparently do just about anything for the bottom line despite their corporate motto.