US 9,808,525 B2
Stable aqueous formulations of adalimumab
Mark Manning, Johnstown, CO (US); and Robert W. Payne, Fort Collins, CO (US)
Assigned to Coherus Biosciences, Inc., Redwood City, CA (US)
Filed by Coherus Biosciences, Inc., Redwood City, CA (US)
Filed on Oct. 9, 2015, as Appl. No. 14/879,885.
Application 14/879,885 is a continuation of application No. 14/020,733, filed on Sep. 6, 2013.
Claims priority of provisional application 61/698,138, filed on Sep. 7, 2012.
Claims priority of provisional application 61/769,581, filed on Feb. 26, 2013.
Claims priority of provisional application 61/770,421, filed on Feb. 28, 2013.
Prior Publication US 2016/0031982 A1, Feb. 4, 2016
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); C07K 16/24 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/24 (2006.01); A61K 9/08 (2006.01); A61K 39/00 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/08 (2013.01); A61K 39/3955 (2013.01); A61K 39/39533 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/18 (2013.01); A61K 47/183 (2013.01); A61K 47/22 (2013.01); A61K 47/24 (2013.01); A61K 47/26 (2013.01); C07K 16/241 (2013.01); A61K 2039/505 (2013.01); A61K 2039/542 (2013.01); A61K 2039/545 (2013.01); C07K 2317/21 (2013.01); C07K 2317/24 (2013.01); C07K 2317/94 (2013.01)] 11 Claims
 
1. An aqueous formulation of adalimumab comprising:
(a) adalimumab;
(b) a buffer selected from the group consisting of citrate, phosphate, histidine, succinate, tartrate, maleate and acetate, and combinations thereof, provided the combinations do not include a combination of citrate buffer and phosphate buffer;
(c) a polyol;
(d) a salt selected from the group consisting essentially of sodium chloride, sodium sulfate, and potassium chloride; and
(e) a surfactant,
wherein the formulation has pH of 4 to 8.