Biosimilars

FDA recently approved BESREMi for the treatment of

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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PRESS RELEASES

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

Press Releases

Biocon Receives Health Canada Approval of Bosaya™ (Denosumab) and Vevzuo™ (Denosumab), Biosimilars to Prolia® and Xgeva®

April 21, 2026

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8 min read

Press Releases

JAMP Pharma Group Strengthens Its Immunology Biosimilars Portfolio with PrUpgolyv™, a Golimumab Biosimilar that has Receive its Notice of Compliance by Health Canada.

April 20, 2026

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5 min read

Press Releases

Samsung Bioepis Highlights Consistent Efficacy of SB16 (OBODENCE®; Denosumab) Across Osteoporosis Patient Subgroups at WCO-IOF-ESCEO 2026

April 17, 2026

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2 min read

Press Releases

Mabwell Establishes a Licensing and Commercialization Agreement for Denosumab Biosimilars in Malaysian Market

April 16, 2026

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4 min read

Press Releases

Mabwell Announces Acceptance of Supplemental Biologics License Application by NMPA for MAIWEIJIAN (Denosumab)

April 16, 2026

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5 min read

Press Releases

CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes for Tyenne® (tocilizumab-aazg)

April 10, 2026

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13 min read

Press Releases

Biocon Announces U.S. Commercial Launch of Bosaya™ and Aukelso™, Denosumab Biosimilars

April 7, 2026

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12 min read

Press Releases

Apotex Strengthens Osteoporosis Care in Canada with Health Canada’s Approval of DENOZA™, a Denosumab Biosimilar

April 7, 2026

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2 min read

Press Releases

Bora Biologics Successfully Completes 2,000L Engineering and Scale-Up Run in San Diego, Reinforcing Commercial-Scale Readiness

April 6, 2026

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4 min read

Press Releases

AEON Biopharma Reports Full Year 2025 Financial Results and Highlights Positive Comparative Analytical Results and FDA Feedback for ABP-450 Biosimilar Program

March 30, 2026

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10 min read

Press Releases

Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)

March 30, 2026

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18 min read

Press Releases

Neion Bio Emerges from Stealth with Multi-Product Biosimilar Partnership Leveraging Its Cutting-Edge Genetic Engineering Platform

March 26, 2026

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5 min read

Press Releases

AEON Biopharma Announces FDA Feedback Following BPD Type 2a Meeting for the ABP-450 Biosimilar Program

March 25, 2026

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4 min read