Claims for Patent: 9,707,293

Summary for Patent: 9,707,293

Title:	Stable aqueous formulations of adalimumab
Abstract:	The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s):	Manning; Mark (Johnstown, CO), Payne; Robert W. (Fort Collins, CO)
Assignee:	Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:	15/155,925
Patent Claims:	1. A buffered aqueous pharmaceutical composition having pH about 5 to about 6 comprising: (i) adalimumab; (ii) a buffer consisting of solely histidine; and (iii) a stabilizer, consisting essentially of an amino acid selected from glycine, arginine, methionine or combinations thereof; wherein the composition does not contain polyol. 2. The composition of claim 1, wherein the amino acid is glycine. 3. The composition of claim 1, wherein the composition comprises sodium chloride or sodium sulfate at a concentration of up to 150 mM. 4. The composition of claim 1 having osmolality of 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab of 30 to 50 mg/ml; and the dosage contains 10 to 80 mg of adalimumab. 5. The composition of claim 4 comprising sodium chloride at a concentration of up to 100 mM and wherein the amino acid consists solely of glycine. 6. The composition of claim 5, wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate. 7. A buffered aqueous pharmaceutical composition having pH about 5 to about 6 comprising: (i) adalimumab at a concentration of 30 to 50 mg/ml; (ii) a buffer consisting solely of histidine; and (iii) a stabilizer, consisting essentially of an amino acid selected from glycine, arginine, methionine or combinations thereof; wherein the composition does not contain polyol. 8. The composition of claim 7, wherein the concentration of adalimumab is about 50 mg/ml. 9. The composition of claim 7, wherein the amino acid is glycine. 10. The composition of claim 9 further comprising a salt, selected from sodium chloride and sodium sulfate, present at a concentration of up to 150 mM. 11. The composition of claim 7 having osmolality of 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; and the dosage contains 10 to 80 mg of adalimumab. 12. The composition of claim 11, wherein the concentration of adalimumab is about 50 mg/ml. 13. The composition of claim 11, wherein the dosage is about 40 mg. 14. The composition of claim 11 comprising sodium chloride present at a concentration of up to 100 mM; and wherein the amino acid is glycine. 15. The composition of claim 14, wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate.

Details for Patent 9,707,293

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2039-02-26