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Chemistry

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Also known as: Gtpl7572, Hoe901, Hoe-901
Molecular Formula
C267H404N72O78S6
Molecular Weight
6063  g/mol
InChI Key
COCFEDIXXNGUNL-RFKWWTKHSA-N

Insulin Glargine
A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.
1 2D Structure

Insulin Glargine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S)-4-[[2-[[(1R,6R,12S,15S,18S,21S,24S,27S,30S,33S,36S,39S,42R,47R,50S,53S,56S,59S,62S,65S,68S,71S,74R,77S,80S,83S,88R)-88-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3S)-2-[(2-aminoacetyl)amino]-3-methylpentanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]-6-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-amino-3-phenylpropanoyl]amino]-3-methylbutanoyl]amino]-4-oxobutanoyl]amino]-5-oxopentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-53-(2-amino-2-oxoethyl)-62-(3-amino-3-oxopropyl)-77-[(2S)-butan-2-yl]-24,56-bis(2-carboxyethyl)-47-(carboxymethylcarbamoyl)-83-[(1R)-1-hydroxyethyl]-12,71,80-tris(hydroxymethyl)-33,50,65-tris[(4-hydroxyphenyl)methyl]-15-(1H-imidazol-5-ylmethyl)-27-methyl-18,30,36,59,68-pentakis(2-methylpropyl)-7,10,13,16,19,22,25,28,31,34,37,40,49,52,55,58,61,64,67,70,73,76,79,82,85,87-hexacosaoxo-21,39-di(propan-2-yl)-3,4,44,45,90,91-hexathia-8,11,14,17,20,23,26,29,32,35,38,41,48,51,54,57,60,63,66,69,72,75,78,81,84,86-hexacosazabicyclo[72.11.7]dononacontane-42-carbonyl]amino]acetyl]amino]-5-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S,3R)-1-[(2S)-2-[[(2S)-6-amino-1-[[(2S,3R)-1-[[(2S)-5-carbamimidamido-1-[[(1S)-4-carbamimidamido-1-carboxybutyl]amino]-1-oxopentan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxohexan-2-yl]carbamoyl]pyrrolidin-1-yl]-3-hydroxy-1-oxobutan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
2.1.2 InChI
InChI=1S/C267H404N72O78S6/c1-29-137(23)212(330-199(355)109-269)260(412)334-211(136(21)22)256(408)305-166(79-86-206(365)366)226(378)298-163(75-82-196(273)352)230(382)326-190-122-421-422-123-191-251(403)322-185(117-341)249(401)312-170(94-129(7)8)234(386)313-176(101-146-57-65-152(346)66-58-146)237(389)299-161(73-80-194(271)350)227(379)308-169(93-128(5)6)232(384)301-165(78-85-205(363)364)229(381)320-182(107-197(274)353)244(396)316-178(103-148-61-69-154(348)70-62-148)240(392)325-188(222(374)290-115-207(367)368)120-418-420-121-189(221(373)288-112-200(356)294-160(76-83-203(359)360)225(377)297-157(53-42-88-284-265(276)277)219(371)287-113-201(357)295-174(99-144-48-36-32-37-49-144)236(388)315-175(100-145-50-38-33-39-51-145)239(391)317-179(104-149-63-71-155(349)72-64-149)247(399)338-216(142(28)345)263(415)339-91-45-56-193(339)254(406)302-158(52-40-41-87-268)231(383)336-214(140(26)343)261(413)303-159(54-43-89-285-266(278)279)224(376)306-167(264(416)417)55-44-90-286-267(280)281)328-258(410)210(135(19)20)333-245(397)172(96-131(11)12)310-238(390)177(102-147-59-67-153(347)68-60-147)314-233(385)168(92-127(3)4)307-217(369)139(25)293-223(375)164(77-84-204(361)362)304-255(407)209(134(17)18)332-246(398)173(97-132(13)14)311-242(394)181(106-151-111-283-126-292-151)319-248(400)184(116-340)296-202(358)114-289-220(372)187(119-419-423-124-192(327-252(190)404)253(405)337-215(141(27)344)262(414)323-186(118-342)250(402)335-213(138(24)30-2)259(411)329-191)324-235(387)171(95-130(9)10)309-241(393)180(105-150-110-282-125-291-150)318-228(380)162(74-81-195(272)351)300-243(395)183(108-198(275)354)321-257(409)208(133(15)16)331-218(370)156(270)98-143-46-34-31-35-47-143/h31-39,46-51,57-72,110-111,125-142,156-193,208-216,340-349H,29-30,40-45,52-56,73-109,112-124,268-270H2,1-28H3,(H2,271,350)(H2,272,351)(H2,273,352)(H2,274,353)(H2,275,354)(H,282,291)(H,283,292)(H,287,371)(H,288,373)(H,289,372)(H,290,374)(H,293,375)(H,294,356)(H,295,357)(H,296,358)(H,297,377)(H,298,378)(H,299,389)(H,300,395)(H,301,384)(H,302,406)(H,303,413)(H,304,407)(H,305,408)(H,306,376)(H,307,369)(H,308,379)(H,309,393)(H,310,390)(H,311,394)(H,312,401)(H,313,386)(H,314,385)(H,315,388)(H,316,396)(H,317,391)(H,318,380)(H,319,400)(H,320,381)(H,321,409)(H,322,403)(H,323,414)(H,324,387)(H,325,392)(H,326,382)(H,327,404)(H,328,410)(H,329,411)(H,330,355)(H,331,370)(H,332,398)(H,333,397)(H,334,412)(H,335,402)(H,336,383)(H,337,405)(H,338,399)(H,359,360)(H,361,362)(H,363,364)(H,365,366)(H,367,368)(H,416,417)(H4,276,277,284)(H4,278,279,285)(H4,280,281,286)/t137-,138-,139-,140+,141+,142+,156-,157-,158-,159-,160-,161-,162-,163-,164-,165-,166-,167-,168-,169-,170-,171-,172-,173-,174-,175-,176-,177-,178-,179-,180-,181-,182-,183-,184-,185-,186-,187-,188-,189-,190-,191-,192-,193-,208-,209-,210-,211-,212-,213-,214-,215-,216-/m0/s1
2.1.3 InChI Key
COCFEDIXXNGUNL-RFKWWTKHSA-N
2.1.4 Canonical SMILES
CCC(C)C1C(=O)NC2CSSCC(C(=O)NC(CSSCC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)NCC(=O)O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CC5=CC=CC=C5)C(=O)NC(CC6=CC=CC=C6)C(=O)NC(CC7=CC=C(C=C7)O)C(=O)NC(C(C)O)C(=O)N8CCCC8C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CN=CN2)CO)NC(=O)C(CC(C)C)NC(=O)C(CC2=CN=CN2)NC(=O)C(CCC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(C(C)C)NC(=O)C(CC2=CC=CC=C2)N)C(=O)NC(C(=O)NC(C(=O)N1)CO)C(C)O)NC(=O)C(CCC(=O)N)NC(=O)C(CCC(=O)O)NC(=O)C(C(C)C)NC(=O)C(C(C)CC)NC(=O)CN
2.1.5 Isomeric SMILES
CC[C@H](C)[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)NCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)NCC(=O)O)C(=O)NCC(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CC5=CC=CC=C5)C(=O)N[C@@H](CC6=CC=CC=C6)C(=O)N[C@@H](CC7=CC=C(C=C7)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N8CCC[C@H]8C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CN=CN2)CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC2=CN=CN2)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC2=CC=CC=C2)N)C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CO)[C@@H](C)O)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)[C@H]([C@@H](C)CC)NC(=O)CN
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 901, Hoe

2. A21 Gly B31 Arg B32 Arg Insulin

3. A21-gly-b31-arg-b32-arg-insulin

4. Basaglar

5. Glargine

6. Glargine, Insulin

7. Glargine-aglr, Insulin

8. Hoe 901

9. Hoe-901

10. Hoe901

11. Insulin Glargine

12. Insulin Glargine-aglr

13. Insulin Glargine-yfgn

14. Insulin, Gly(a21)-arg(b31,b32)

15. Insulin, Glycyl(a21)-arginyl(b31,b32)

16. Lantus

17. Lantus Solostar

18. Rezvoglar

19. Semglee

20. Solostar, Lantus

2.2.2 Depositor-Supplied Synonyms

1. Gtpl7572

2. Hoe901

3. Hoe-901

2.3 Create Date
2009-08-20
3 Chemical and Physical Properties
Molecular Weight 6063 g/mol
Molecular Formula C267H404N72O78S6
XLogP3-14.1
Hydrogen Bond Donor Count85
Hydrogen Bond Acceptor Count92
Rotatable Bond Count191
Exact Mass6060.8251182 g/mol
Monoisotopic Mass6058.8184085 g/mol
Topological Polar Surface Area2590 Ų
Heavy Atom Count423
Formal Charge0
Complexity15300
Isotope Atom Count0
Defined Atom Stereocenter Count53
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameLantus
PubMed HealthInsulin Glargine
Drug ClassesAntidiabetic, Insulin, Long Acting
Drug LabelLANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter...
Active IngredientInsulin glargine recombinant
Dosage FormInjectable
RouteInjection
Strength100 units/ml
Market StatusPrescription
CompanySanofi Aventis Us

2 of 2  
Drug NameLantus
PubMed HealthInsulin Glargine
Drug ClassesAntidiabetic, Insulin, Long Acting
Drug LabelLANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter...
Active IngredientInsulin glargine recombinant
Dosage FormInjectable
RouteInjection
Strength100 units/ml
Market StatusPrescription
CompanySanofi Aventis Us

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)


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Biocon

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Tonghua Dongbao Pharma

China

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Tonghua Dongbao Pharma

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Ningbo Inno Pharmchem

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Nanogen Pharmaceutical Biotechnolo...

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Wockhardt

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Insulin Glargine

About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...

Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are proud to be the leading company in the Asia-Pacific region that successfully researched and developed Active Pharmaceutical Ingredients (APIs) and specific therapeutic products on the foundation of advanced recombinant DNA/protein technology.
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Insulin Glargine

About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...

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API Reference Price

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15-Jan-2021
28-Oct-2024
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Drugs in Development

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Details:

Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.


Lead Product(s): Insulin Glargine,Lixisenatide

Therapeutic Area: Endocrinology Brand Name: Soliqua

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 27, 2023

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01

Sanofi

France
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Antibody Engineering
Not Confirmed

Lead Product(s) : Insulin Glargine,Lixisenatide

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.

Brand Name : Soliqua

Molecule Type : Peptide

Upfront Cash : Not Applicable

March 27, 2023

Sanofi Company Banner

Details:

Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.


Lead Product(s): Insulin Glargine,Lixisenatide

Therapeutic Area: Endocrinology Brand Name: Soliqua

Study Phase: UndisclosedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 28, 2021

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02

Sanofi

France
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Antibody Engineering
Not Confirmed

Lead Product(s) : Insulin Glargine,Lixisenatide

Therapeutic Area : Endocrinology

Highest Development Status : Undisclosed

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.

Brand Name : Soliqua

Molecule Type : Peptide

Upfront Cash : Not Applicable

June 28, 2021

Sanofi Company Banner

Details:

Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing facilities.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Peptide

Sponsor: Civica Rx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership January 31, 2023

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03

Ypsomed

Switzerland
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Antibody Engineering
Not Confirmed

Ypsomed

Switzerland
arrow
Antibody Engineering
Not Confirmed

Details : Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing...

Brand Name : Undisclosed

Molecule Type : Peptide

Upfront Cash : Undisclosed

January 31, 2023

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Details:

Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Glaricon

Study Phase: ApprovedProduct Type: Peptide

Sponsor: HEC Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2022

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04

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer re...

Brand Name : Glaricon

Molecule Type : Peptide

Upfront Cash : Not Applicable

August 31, 2022

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Details:

The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: HEC-Glargine

Study Phase: Phase IProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 29, 2022

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05

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.

Brand Name : HEC-Glargine

Molecule Type : Peptide

Upfront Cash : Not Applicable

March 29, 2022

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Details:

Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Insulin Glargine-Generic

Study Phase: PreclinicalProduct Type: Peptide

Sponsor: GeneSys Biologics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing March 03, 2022

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06

Civica Rx

U.S.A
arrow
Antibody Engineering
Not Confirmed

Civica Rx

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.

Brand Name : Insulin Glargine-Generic

Molecule Type : Peptide

Upfront Cash : Undisclosed

March 03, 2022

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Details:

The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin Glargine-yfgn).


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Semglee

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Biocon

Deal Size: $3,335.0 million Upfront Cash: $2,335.0 million

Deal Type: Acquisition February 28, 2022

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07

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin ...

Brand Name : Semglee

Molecule Type : Peptide

Upfront Cash : $2,335.0 million

February 28, 2022

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Details:

The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Semglee

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Biocon

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 18, 2022

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08

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefille...

Brand Name : Semglee

Molecule Type : Peptide

Upfront Cash : Not Applicable

January 18, 2022

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Details:

Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2 diabetes.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Semglee

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 29, 2021

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09

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2...

Brand Name : Semglee

Molecule Type : Peptide

Upfront Cash : Not Applicable

December 29, 2021

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Details:

Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries.


Lead Product(s): Insulin Glargine

Therapeutic Area: Endocrinology Brand Name: Glaricon

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Biocon

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 07, 2021

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10

Tabuk Pharmaceuticals

Saudi Arabia
arrow
Antibody Engineering
Not Confirmed

Tabuk Pharmaceuticals

Saudi Arabia
arrow
Antibody Engineering
Not Confirmed

Details : Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries...

Brand Name : Glaricon

Molecule Type : Peptide

Upfront Cash : Undisclosed

December 07, 2021

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Europe

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01

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Sweden

insulin glargine

Brand Name : Lantus (ClikSTAR others. Pens)

Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE

Dosage Strength : 100 UNITS / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

02

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Sweden

insulin glargine

Brand Name : Lantus (OptiClik)

Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE

Dosage Strength : 100 UNITS / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

03

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Sweden

insulin glargine

Brand Name : Toujeo

Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED

Dosage Strength : 100 UNITS / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

04

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Sweden

insulin glargine

Brand Name : Toujeo

Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED

Dosage Strength : 300 UNITS / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

05

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Italy

Glargine

Brand Name : Lantus

Dosage Form : Insulin Glargine 1.000Iu 10Ml 1 Units Parenteral Use

Dosage Strength : 1 vial SC 1,000 IU 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

06

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Italy

Glargine

Brand Name : Lantus

Dosage Form : Insulin Glargine 100Iu/Ml 3Ml 5 Units Parenteral Use

Dosage Strength : 5 cartridges SC 100 IU/ml 3 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

07

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Glargine

Brand Name : Lantus

Dosage Form : Injection fluid, resolution in the finished filled pen

Dosage Strength : 100 E/ml

Packaging : Finish filled pen, solo star

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

08

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Glargine

Brand Name : Toujeo

Dosage Form : Injection fluid, resolution

Dosage Strength : 300 E/ml

Packaging : Finish filled pen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

09

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Glargine

Brand Name : Toujeo

Dosage Form : Injection fluid, resolution

Dosage Strength : 300 E/ml

Packaging : Finish filled pen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

10

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Insulinum glarginum; Lixisenatidum

Brand Name : Suliqua 100/33

Dosage Form : Inj Loose Solostar

Dosage Strength : 100/33

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Listed Dossiers

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01

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

Insulin Glargine

Brand Name :

Dosage Form : Injection

Dosage Strength : 300IU/3ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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01

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Insulin Glargine

Dosage : Injection

Dosage Strength : 300IU/3ML

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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01

Brand Name : Lantus

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2014 Revenue in Millions : 11.00%

2013 Revenue in Millions :

Growth (%) :

Sanofi Company Banner

02

Brand Name : Lantus

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2019 Revenue in Millions : 3,283

2018 Revenue in Millions : 3,886

Growth (%) : -16

Sanofi Company Banner

03

Brand Name : Toujeo

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2019 Revenue in Millions : 962

2018 Revenue in Millions : 916

Growth (%) : 5

Sanofi Company Banner

04

Brand Name : Toujeo

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2020 Revenue in Millions : 1,129

2019 Revenue in Millions : 1,068

Growth (%) : 6

Sanofi Company Banner

05

Brand Name : Soliqua/iGlarLixi

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2020 Revenue in Millions : 195

2019 Revenue in Millions : 148

Growth (%) : 32

Sanofi Company Banner

06

Brand Name : Lantus

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2020 Revenue in Millions : 3,219

2019 Revenue in Millions : 3,643

Growth (%) : -12

Sanofi Company Banner

07

Brand Name : Lantus

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2021 Revenue in Millions : 2,746

2020 Revenue in Millions : 2,900

Growth (%) : -6

Sanofi Company Banner

08

Brand Name : Toujeo

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2021 Revenue in Millions : 1,067

2020 Revenue in Millions : 1,017

Growth (%) : 4

Sanofi Company Banner

09

Brand Name : Soliqua/iGlarLixi

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2021 Revenue in Millions : 215

2020 Revenue in Millions : 175

Growth (%) : 21

Sanofi Company Banner

10

Brand Name : Toujeo

France
arrow
CPHI Middle east
Not Confirmed
Flag France
Digital Content Digital Content
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Insulin Glargine

Main Therapeutic Indication : Diabetes

Currency : USD

2022 Revenue in Millions : 1,225

2021 Revenue in Millions : 1,067

Growth (%) : 15

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