I loved the message JD gave us concerning their lack knowledge of any Enbrel biosimilar: "We're not aware of any. And even then, they'll have to conduct the trials to get approval." I don't know how I stumbled upon it, but it took daaaaaays to Google 'etanercept biosimilar'. Don't piss on my leg ...
wooo this was tough lol Count your days kitties!!! Mycenax to start phase III etanercept biosimilar trial posted 17/11/2009 Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully completed a phase I trial in South Korea and a phase I/II clinical trial in Taiwan is in the data analysis and report preparation stage; important clinical trial milestones towards the commercial release of the drug in both regional and global markets. Mycenax also announced that TuNEX would undergo a phase III clinical trial soon, with plans to also undertake multinational, multicenter phase III studies in several countries such as Korea and India, using the clinical data obtained to apply to market the drug in other locations globally. With the completion of the phase I trial in Korea – a 'biosimilar' as stipulated by Korean drug approval regulations, conducted on 24 healthy patients at National Seoul University – TuNEX becomes the first protein drug developed in Taiwan to pass such a milestone overseas. The Taiwan clinical trial – a 'new drug' as stipulated by Taiwan drug approval regulations –was completed in September 2009 on 18 arthritis patients at the Taichung Veteran General Hospital, Kaohsiung Veteran General Hospital and Buddhist Tzu Chi General Hospital. The final report will be completed at the end of 2009, reported Dr Karen Wen, spokesperson and Vice President at Mycenax. Dr Michael Hwang, Mycenax Founder and President said, “With TuNEX being an INN etanercept biosimilar to Enbrel, the world's largest biological pharmaceutical with over US$6 billion (Euros 4.04 billion) in sales, we expect that TuNEX will become a successful, popular cost-effective alternative.” The development of Taiwan's first biosimilar is also welcome news for the country's fledgling biotech sector. “With the drug ready to enter phase III trials, it’s indicative of the strength and potential of the biotechnology industry in Taiwan that a small company [50 employees] can produce and develop such an international class drug and compete on global markets,” Dr Hwang said. Hey Have a nice day !!
You need to get your heads out of your asses. There is no biosimilar approval process in the US and when one is implemented it will be similar to the EU's and require full testing and FDA approval. If you think that the FDA is going to allow a biologic from Taiwan to be marketed in the US without additional US controlled trials then you are fucked in the head. Add to that the only place Amgen markets Enbrel is in NA so the phase 3 trail that you posted isn't worth shit as far as Amgen is concerned.
