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Biosimilars
FDA
New Day For Diabetes Patients As FDA Approves First-Ever Interchangeable Biosimilar
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
July 29, 2021
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2 min read
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Mark Terry
PRESS RELEASES
Press Releases
Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA
June 23, 2026
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5 min read
Press Releases
Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada
June 18, 2026
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6 min read
Press Releases
Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®
June 8, 2026
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6 min read
Press Releases
Gedeon Richter Highlights Expanding Biosimilars Portfolio and Scientific Engagement at EULAR 2026
June 4, 2026
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2 min read
Press Releases
Teva Expands European biosimilars portfolio with launch of AHZANTIVE® (aflibercept) biosimilar to Eylea®
June 4, 2026
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5 min read
Press Releases
Kashiv BioSciences Announces Validation and Acceptance of Market Authorization Application by Health Canada for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)
June 4, 2026
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2 min read
Press Releases
Bio‑Techne and Refeyn Close Critical Gap in Bispecific Antibody and Biosimilar Characterization
June 4, 2026
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4 min read
Press Releases
Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea®
June 4, 2026
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6 min read
Press Releases
Polpharma Biologics and Tuteur Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases
May 22, 2026
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3 min read
Press Releases
Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch in Japan
May 20, 2026
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2 min read
Press Releases
Bio-Thera Solutions’ Golimumab Biosimilars Receive FDA Approval as First Biosimilars to Simponi® and Simponi Aria®; Accord BioPharma to Commercialize IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) in the United States - May 18, 2026
May 18, 2026
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7 min read
Press Releases
FDA Approves IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi), First Biosimilars to Simponi® (golimumab) and Simponi Aria® (golimumab); Accord BioPharma to Lead U.S. Commercialization
May 18, 2026
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14 min read
Press Releases
IQVIA and Kexing Biopharm Expand Strategic Collaboration to Accelerate Global Biosimilar Development using AI-Enabled Capabilities
May 14, 2026
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4 min read
Press Releases
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)
May 6, 2026
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3 min read
Press Releases
Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA Approval of LANGLARA™ an Interchangeable Biosimilar of Lantus® (insulin glargine)
May 4, 2026
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5 min read
Press Releases
Teva Delivers Strong Q1 2026 Results Driven by Innovative Portfolio Growth and Disciplined Execution
April 29, 2026
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50 min read
Press Releases
European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe
April 29, 2026
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8 min read
Press Releases
Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report
April 27, 2026
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4 min read
Press Releases
Kashiv BioSciences Agrees to Be Acquired by Amneal Pharmaceuticals to Create a Fully Integrated Global Biosimilar Leader
April 22, 2026
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4 min read
Press Releases
Amneal Agrees to Acquire Kashiv BioSciences to Create Global Biosimilar Leader; Reports Strong Preliminary First Quarter 2026 Financial Results and Raises FY2026 Standalone Guidance
April 22, 2026
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27 min read
