Claims for Patent: 9,789,185

Summary for Patent: 9,789,185

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:	15/155,982
Patent Claims:	1. A buffered aqueous pharmaceutical composition having pH about 5 to about 6 comprising: (i) adalimumab; (ii) buffer; and (iii) stabilizer; wherein the composition is free of both polyol and surfactant. 2. The composition of claim 1, wherein the stabilizer is selected from the group consisting of an amino acid, a salt, EDTA and a metal ion. 3. The composition of claim 2, wherein the amino acid is selected from the group consisting of glycine, arginine and combinations thereof. 4. The composition of claim 2, wherein the salt is selected from the group consisting of sodium chloride and sodium sulfate. 5. The composition of claim 4, wherein the salt is, or includes, sodium sulfate. 6. The composition of claim 1, wherein the buffer contains no citrate and consists of histidine, succinate, or a combination thereof. 7. The composition of claim 1, wherein the composition has a concentration of adalimumab of 30 to 50 mg/ml. 8. The composition of claim 7, wherein the concentration of adalimumab is about 50 mg/ml. 9. The composition of claim 6, wherein histidine is the sole buffer in the composition; the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab in the range of 30 to about 50 mg/ml; and the dosage contains about 10 to 80 mg of adalimumab. 10. The composition of claim 9, wherein the dosage is about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate. 11. A buffered aqueous pharmaceutical composition having pH about 5 to about 6 comprising: (i) adalimumab; (ii) buffer consisting essentially of histidine, succinate, or both; and (iii) a stabilizer, consisting essentially of: (a) an amino acid selected from glycine, alanine, glutamate, arginine, methionine, and combinations thereof; or (a) and (b), where (b) is sodium chloride, sodium sulfate or both; wherein the composition is free of both polyol and surfactant. 12. The composition of claim 11, comprising histidine as the sole buffer, and glycine. 13. The composition of claim 11, comprising histidine as the sole buffer, and arginine. 14. The composition of claim 11, wherein (b) is, or includes, sodium sulfate. 15. The composition of claim 11, wherein (b) is, or includes, sodium chloride. 16. The composition of claim 11, wherein the composition has a concentration of adalimumab of 30 to 50 mg/ml. 17. The composition of claim 16, wherein the concentration of adalimumab is about 50 mg/ml. 18. The composition of claim 11 having osmolality of about 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 in the range of 30 to about 50 mg/ml; and the dosage contains about 10 to 80 mg of adalimumab. 19. The composition of claim 18, wherein the dosage is about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer comprising citrate. 20. An aqueous buffered pharmaceutical composition having pH about 5 to about 6 comprising adalimumab and a citrate-free buffer, wherein the composition is free of both polyol and surfactant. 21. The composition of claim 20, wherein the composition has a concentration of adalimumab of 30 to 50 mg/ml. 22. The composition of claim 21, wherein the concentration of adalimumab is about 50 mg/ml. 23. The composition of claim 20 comprising: (i) adalimumab; (ii) buffer consisting solely of histidine, succinate, or combination thereof; and (iii) glycine, arginine or both. 24. The composition of claim 23 further comprising a salt selected from sodium chloride and sodium sulfate. 25. The composition of claim 23 having osmolality of about 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; said composition having a concentration of adalimumab in the range of 30 to about 50 mg/ml; and the dosage contains about 10 to 80 mg of adalimumab. 26. The composition of claim 25, wherein the concentration of adalimumab is about 50 mg/ml. 27. The composition of claim 25, wherein the dosage is about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer comprising citrate.

Details for Patent 9,789,185

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
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10/17/2016		2039-02-26