BLG 699 Chapter 4: BLG699 WEEK 4 TEXTBOOK NOTES

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If you"re submitting biologics to health canada, you submit it to bgtd. For the fda, you"re submitting the cber; sometimes for antibodies you can submit it to cder. Importance: as you move forward, the top drugs are biologics. 10 biologics on best selling drugs list for 2016. Mega blockbuster humira continues to grab headlines. Textbook notes: revlimid (lenalidomide) - . 7b, prevnar 13 (pneumococcal 13 -- valent conjugate vaccine) - . 1b, remicade (infliximab) - . 8b, advair (fluticasone/salmeterol) - b. However, several biologics are up for patent loss in the next decade which opens the doors for newly developed and cheaper bio-similar. More potent and specific, similar to the proteins within the body. Three major types as prophylactic (preventive, as in the case of vaccines), therapeutic (antibodies), and replacement (hormones, growth factors) therapy. 110 canadian biopharmaceutical small and medium enterprises (smes) with over 325 promising biopharmaceutical products in human health under development.

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