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Last Updated: April 26, 2024

Claims for Patent: 10,493,152

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Summary for Patent: 10,493,152

Title:	Adalimumab formulations
Abstract:	The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
Inventor(s):	Rinaldi; Gianluca (Monterotondo, RO), Fratarcangeli; Silvia (Ceprano, IT), Del Rio; Alessandra (Rome, IT)
Assignee:	Fresenius Kabi Deutschland GmbH (Bad Homburg, DE)
Application Number:	15/313,480
Patent Claims:	1. An aqueous pharmaceutical composition comprising: (a) 45-55 mg/mL adalimumab; (b) a histidine buffering agent or histidine buffer system; (c) 100-250 mM sorbitol; and (d) 0.05 mg/mL to 1.5 mg/mL Polysorbate 20 and Polysorbate 80; wherein the composition: has a pH between 5.0 and 6.7; is free of amino acids other than histidine; and is free of phosphate buffering agents; and comprises at most one sugar stabilizer. 2. The aqueous pharmaceutical composition of claim 1, wherein the adalimumab is present at a concentration of 50 mg/mL. 3. The aqueous pharmaceutical composition of claim 1, wherein the histidine buffering agent or histidine buffer system is present at a concentration of at least 5 mM. 4. The aqueous pharmaceutical composition of claim 1, wherein the sorbitol is present at a concentration of 100-210 mM. 5. The aqueous pharmaceutical composition of claim 1, wherein the polysorbate 20 is present at a concentration of 0.5 to 1.1 mg/mL. 6. The aqueous pharmaceutical composition of claim 1, wherein the composition further comprises a citrate buffer. 7. The aqueous pharmaceutical composition of claim 1, wherein the composition further comprises sodium chloride as a tonicifier present at a concentration of 25 to 75 mM. 8. The aqueous pharmaceutical composition of claim 1, wherein the sorbitol is present at a concentration of 100 to 150 mM. 9. The aqueous pharmaceutical composition of claim 1, wherein the composition comprises a non-buffering tonicifier which is the sorbitol. 10. The aqueous pharmaceutical composition of claim 1, wherein the composition comprises only a single non-buffering tonicifier, which is the sorbitol. 11. The aqueous pharmaceutical composition of claim 1, wherein the pH of the composition is between 5.0 and 6.0. 12. The aqueous pharmaceutical composition of claim 1, wherein the composition consists of: (a) 45-55 mg/mL adalimumab; (b) a histidine buffer system alone or in combination with a further buffer system; (c) 100-200 mM sorbitol; (d) 0.05-1.5 mg/mL polysorbate 20; and (e) water; wherein the composition has a pH between 5.0 and 6.5. 13. The aqueous pharmaceutical composition of claim 1, wherein the composition consists of: (a) 50 mg/mL adalimumab; (b) a histidine buffer system alone or in combination with a further buffer system; (c) 100-150 mM sorbitol; (d) 0.5-1.1 mg/mL polysorbate 20; and (e) water; wherein the composition has a pH between 5.0 and 6.0. 14. The aqueous pharmaceutical composition of claim 1, wherein the composition consists of: (a) 50 mg/mL adalimumab; (b) a buffer system consisting of a histidine buffer system and a citrate buffer system; (c) 100-150 mM sorbitol; (d) 0.5-1.5 mg/mL polysorbate 20; and (e) water; wherein the composition has a pH between 5.0 and 6.0.

Details for Patent 10,493,152

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016	⤷ Try a Trial	2034-05-23
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10/17/2016	⤷ Try a Trial	2034-05-23
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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