Bioequivalence and Bioavailability Forum

drgunasakaran1 ★★ 2014-05-15 06:13 (4430 d 01:00 ago) Posting: # 12946 Views: 3,494	FDA’s Draft guidance on Demonstration of Biosimilarity [Regulatives / Guidelines] Post reply
	Dear all, FDA released Draft guidance on Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product To see the FDA's Guidance, click here — *Dr Gunasakaran Sambandan MD* Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

ElMaestro ★★★ Denmark, 2014-05-15 12:44 (4429 d 18:29 ago) @ drgunasakaran1 Posting: # 12948 Views: 2,755	FDA’s Draft guidance on Demonstration of Biosimilarity Post reply
	Hi Dr Gunasakaran, thanks for posting. I wonder if they actually pay people to complicate matters by developing linguistically sophisticated terms that increase confusion while adding no real guidance? Some employee deserves a serious promotion for coming up with "orthogonal biosimilarity". — Pass or fail! ElMaestro

drgunasakaran1 ★★ 2014-05-18 19:34 (4426 d 11:40 ago) @ ElMaestro Posting: # 12965 Views: 2,534	FDA’s Draft guidance on Demonstration of Biosimilarity Post reply
	Dear Mr ElMaestro, I fully agree with your views. The new guidance is so confusing. — *Dr Gunasakaran Sambandan MD* Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

FDA’s Draft guidance on Demonstration of Bio­simi­larity [Regulatives / Guidelines]