Semglee® (insulin glargine-yfgn)

aBL 210605 / aBL 761201

Semglee® (insulin glargine-yfgn)

aBL 210605 / aBL 761201

U.S. License Holder:

Mylan Pharms. Inc.

Date of License:

June-11-2020; July-28-2021 (Interchangeable)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

SEMGLEE (insulin glargine) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Semglee® (Mylan / Biocon) (March-2018)

Biosimilars Approved In Australia

Semglee® (Mylan / Biocon) (March-2018)

Biosimilars Approved In Japan

Insulin glargine BS (Biocon / Fujifilm Pharma) (March-2016)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2017-01526

U.S. Patent No.
7,476,652 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-25

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1368 (Lead appeal, consolidated with 19-1369)

Supreme Court Appeal(s)
19A886; 19-1451

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied

IPR2017-01528

U.S. Patent No.
7,713,930 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-20

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1369 (Consolidated with lead appeal 19-1368)

Supreme Court Appeal(s)
19A886; 19-1451

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied

IPR2018-01670

U.S. Patent No.
8,679,069 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claim 1

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1871 (Lead appeal, consolidated with 20-2029, 20-2032, 20-2033, 20-2034, 20-2159)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01675

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 11, 14, 15, 18, 19

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2029 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot

IPR2018-01676

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 11, 14, 15, 18, 19

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2032 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01677

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 51-57

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 54-56

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision - Petitioner Requested Dismissal Due to Clerical Error i

IPR Status
Dismissed at Petitioner's Request Prior to Institution Decision. Refiled as IPR2019-00122.

IPR2018-01678

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, 38-40

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2033 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01679

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 51-57

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 54-56

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2066 (Lead appeal, consolidated with 20-2068, 20-2069)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed

IPR2018-01680

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y: Claims 21-29

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 24-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2068 (Consolidated with lead appeal 20-2066)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed

IPR2018-01682

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 21-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2069 (Consolidated with lead appeal 20-2066)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Dismissed as Moot

IPR2018-01684

U.S. Patent No.
9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3, 7, 8, 11, 17

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2071; 20-2139 and 20-2144 (Cross appeals) (Cross appeals consolidated with lead appeal 20-2071)

IPR Status
Final Written Decision (Some Instituted Claims Found Unpatentable); Federal Circuit Appeals 20-2139 and 20-2144 Withdrawn; Federal Circuit Appeal 20-2071 Affirmed

IPR2018-01696

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 21-30

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

IPR2019-00122

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.; Becton, Dickinson and Company

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-6, 12-18, 20, 23, 26-30, 32, 33, 36, 38-40

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-2034 (Consolidated with lead appeal 20-1871)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot

IPR2019-01657

U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Mylan Pharmaceuticals Inc.; Biocon Biologics Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
21-1981

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Reversed

IPR2019-01658

U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:17-cv-09105 (D.N.J.)

U.S. Patent Nos.
7,476,652 (Acidic Insulin Preparations having Improved Stability) 7,713,930 (Acidic Insulin Preparations having Improved Stability) 7,918,833 (Pen-Type Injector) 8,512,297 (Pen-Type Injector) 8,556,864 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 8,603,044 (Pen-Type Injector) 8,679,069 (Pen-Type Injector) 8,992,486 (Pen-Type Injector) 9,011,391 (Pen-Type Injector) 9,233,211 (Relating to a Pen-Type Injector) 9,408,979 (Pen-Type Injector) 9,526,844 (Pen-type Injector) 9,533,105 (Drive Mechanisms Suitable For Use In Drug Delivery Devices) 9,561,331 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,009 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,610,409 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,623,189 (Relating to Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Plaintiffs
Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH; Sanofi Winthrop Industrie

Defendants
Mylan Pharmaceuticals, Inc.; Mylan GmbH; Mylan Inc.; Mylan NV

Federal Circuit Appeal(s)
21-1262

Status
652 and '930 Patents: PTAB Found All Claims Unpatentable in IPRs; Federal Circuit Affirmed; Supreme Court Denied Certiorari; '044 and '069 Patents: District Court Decision Finding Patents Not Infringed; '486 and '008 Patents: Parties Dismissed Challenges; '844 Patent: District Court Decision Finding Claims 21, 22, 25 and 30 Not Infringed and Invalid; Federal Circuit Appeal Dismissed as Moot

BPCIA
N

Related News

Spotlight On: Biosimilar Litigations
April Breyer Menon Ha Kung Wong
November 30, 2024
Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin glargine) / Rezvoglar™ (insulin glargine-aglr)
April Breyer Menon Damineh Morsali, Ph.D. Corinne E. Atton Robert S. Schwartz, Ph.D.
November 30, 2024
Venable’s BiologicsHQ Monthly Injection – September 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
October 11, 2024
Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
August 10, 2024
Venable’s BiologicsHQ Monthly Injection – June 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
July 9, 2024
Venable’s BiologicsHQ Monthly Injection – May 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
June 11, 2024
Venable’s BiologicsHQ Monthly Injection – April 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
May 16, 2024
Venable’s BiologicsHQ Monthly Injection – March 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
April 10, 2024
Venable’s BiologicsHQ Monthly Injection – February 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
March 13, 2024
Venable’s BiologicsHQ Monthly Injection – January 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
February 13, 2024
Venable’s BiologicsHQ Monthly Injection – December 2023
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
January 13, 2024
Venable’s BiologicsHQ Monthly Injection – September 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 16, 2023
Venable’s BiologicsHQ Monthly Injection – August 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 12, 2023
Venable’s BiologicsHQ Monthly Injection – July 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 15, 2023
What Do the Humira Biosimilar / Interchangeable Launches Mean for the Adalimumab Market?
April Breyer Menon Ha Kung Wong
August 7, 2023
Venable’s BiologicsHQ Monthly Injection – June 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 15, 2023
Venable’s BiologicsHQ Monthly Injection – May 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 13, 2023
Venable’s BiologicsHQ Monthly Injection – April 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 8, 2023
Venable’s BiologicsHQ Monthly Injection – March 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 10, 2023
Venable’s BiologicsHQ Monthly Injection – February 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 15, 2023
Venable’s BiologicsHQ Monthly Injection – January 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 9, 2023
Venable’s BiologicsHQ Monthly Injection – December 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2023
Venable’s BiologicsHQ Monthly Injection – November 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
December 14, 2022
Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar Interchangeability
April Breyer Menon Ha Kung Wong
November 30, 2022
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
November 14, 2022
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022
Venable’s BiologicsHQ Monthly Injection – August 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 8, 2022
First Interchangeable FDA Approval without a Switching Study
April Breyer Menon Ha Kung Wong
August 31, 2022
Venable’s BiologicsHQ Monthly Injection – July 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 5, 2022
Venable’s BiologicsHQ Monthly Injection – June 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 8, 2022
Venable’s BiologicsHQ Monthly Injection – May 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 7, 2022
Venable’s BiologicsHQ Monthly Injection – April 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 9, 2022
Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 18, 2022
Venable’s BiologicsHQ Monthly Injection – February 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 8, 2022
Viatris and Biocon Launch First Interchangeable Insulin in the U.S.
April Breyer Menon
November 30, 2021
Venable’s BiologicsHQ Monthly Injection – October 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 10, 2021
FDA Approves Boehringer Ingelheim’s Cyltezo® as Interchangeable with Humira®
April Breyer Menon
October 25, 2021
Venable’s BiologicsHQ Monthly Injection – September 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 12, 2021
Venable’s BiologicsHQ Monthly Injection – August 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
September 8, 2021
Venable’s BiologicsHQ Monthly Injection – July 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 11, 2021
FDA Approves Semglee® (Insulin Glargine) as the First Interchangeable Biosimilar in the U.S.
April Breyer Menon
July 29, 2021
Venable’s BiologicsHQ Monthly Injection – June 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 13, 2021
Venable’s BiologicsHQ Monthly Injection – May 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 17, 2021
Venable’s BiologicsHQ Monthly Injection – April 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 12, 2021
Boehringer Ingelheim Applies for Interchangeability Designation for Cyltezo® (adalimumab-adbm)
April Breyer Menon
April 26, 2021
Venable’s BiologicsHQ Monthly Injection – March 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 7, 2021
Venable’s BiologicsHQ Monthly Injection – February 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 9, 2021
Venable’s BiologicsHQ Monthly Injection – January 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 8, 2021
Venable’s BiologicsHQ Monthly Injection – December 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2021
Venable’s BiologicsHQ Monthly Injection – November 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
December 9, 2020
Venable’s BiologicsHQ Monthly Injection – October 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 9, 2020
Venable’s BiologicsHQ Monthly Injection – September 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 8, 2020
Venable’s BiologicsHQ Monthly Injection – August 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 9, 2020
Venable’s BiologicsHQ Monthly Injection – July 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 10, 2020
Venable’s BiologicsHQ Monthly Injection – June 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 9, 2020
It’s a New Set of Rules for Insulin Products Under 351(k)
Ha Kung Wong
June 15, 2020
Venable’s BiologicsHQ Monthly Injection – March 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
April 6, 2018

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha