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Biocon

Venable LLP

EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction

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On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

Goodwin

Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more

Goodwin

Update on Recent International Biosimilar Approvals

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​​​​​​​Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more

Goodwin

Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case

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Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. As we previously reported, the case was expedited, with...more

Goodwin

HUMIRA (adalimumab) Biosimilar Launches

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​​​​​​​In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more

Goodwin

Biocon Biologics Confirms Completion of Multi-Billion Dollar Acquisition of Viatris’ Global Biosimilars Business

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As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of...more

Goodwin

Biocon and Alvotech Release Statements on FDA Inspections

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​​​​​​​On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The...more

Goodwin

Biocon Biologics Expands Access to Biosimilars In Over 30 Countries In Africa and Asia

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Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5...more

Goodwin

FDA Defers Decision on Bevacizumab Biosimilar

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The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more...more

Goodwin

Biosimilar Market Update - Biocon Biologics LTD and Samsung Bioepis

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Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injunction from Goldman Sachs. Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable...more

Goodwin

Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

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We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market.  SEMGLEE is a biosimilar of LANTUS, Sanofi’s...more

Goodwin

FDA Approves NDA for Semglee (insulin glargine injection)

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Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.  Semglee’s amino acid...more

Perkins Coie

Part 3: CFTC Finalizes Guidance on Digital Assets in the Context of Retail Commodity Transactions

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This is the third and final part of our update series on the CFTC’s recent Guidance related to the “actual delivery” of a digital asset for purposes of the retail commodity transaction provisions of the Commodity Exchange...more

Goodwin

Mylan and Partner Biocon Win on Insulin Ruling

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We previously reported on Judge Chesler’s claim construction order in Sanofi-Aventis v. Mylan et al. concerning Mylan’s proposed insulin glargine pen device, Vystra. This week, following a 5-day bench trial held on December...more

Goodwin

Biosimilar Developers Comment on Regulatory Delays

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Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. ...more

Goodwin

U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

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Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab). According to the press release, “OGIVRI™ is approved for all indications of...more

Goodwin

Biocon: “Mylan Has Launched” Fulphila™ (pegfilgrastim-jmdb) Biosimilar in the U.S.

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As we previously reported, on June 4, 2018, the U.S. FDA approved Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) as the first biosimilar of Neulasta® to obtain approval in the United States. Mylan stated at the time that...more

Goodwin

Biocon Biosimilars Facility Receives EU GMP Certification

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Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also...more

Goodwin

Update on Biosimilar Launches and Development

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Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for...more

Goodwin

Pipeline Updates for Follow-on Insulin Products: Biocon/Mylan and Polus

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On February 21, 2018, Biocon reported that the FDA issued a Form 483 with six observations after the FDA completed a pre-approval inspection of the facility where Biocon plans to manufacture, in collaboration with Mylan, its...more

Goodwin

Pipeline Updates from Clover, Pfizer, and Mylan/Biocon

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Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new...more

Goodwin

Sandoz announces collaboration with Biocon on next-generation biosimilars

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Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms...more

Goodwin

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

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Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that...more

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