FDA bugüne kadar dokuz biyobenzer onayladı  , ancak devam eden patent davası ve rekabeti içinde arasındaki anlaşmalar nedeniyle sadece üç tanesi pazara ulaştı!

FDA Çalışmaları , benzer biyolojisinin ABD sağlık sistemini, önümüzdeki on yıl içinde 24 milyar dolar ile 150 milyar dolar arasında bir yere çıkarmaya yardımcı olabileceğini tahmin ediyor.

Gottlieb: FDA working on new biosimilar policies

Dive Brief:

• Food and Drug Administration Commissioner Scott Gottlieb told an audience at the CNBC Healthy Returns conference on Wednesday that the agency is going to address the challenges facing biosimilars manufacturers, including “taking a hard look at interchangeability.”
• “I think it’s still early days,” commented Gottlieb on biosimilars. “I think a lot of the initial estimates in how much we would save on biosimilars in advance of legislation probably weren’t realistic. . .I think we will see a lot of biosimilars competition come on the market and that we will see more consumer and buyer acceptance.”
• As many as a dozen new policies are on the way to spur biologics to drugmakers tighten up their manufacturing processes.