Latest News

Biopharma | May 27, 2025

Fresenius Receives Positive CHMP Opinion for their Denosumab Biosimilar Candidates

Fresenius announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of its biosimilar candidates to Prolia® (denosumab) and Xgeva® (denosumab).

Medical scientist in hazmat suit working with microscope and laptop computer inside laboratory hospital - Main focus on doctor eye

Biopharma | March 26, 2025

Fresenius receives FDA approval for their Denosumab biosimilars and secures global settlement agreement

Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the FDA.

Gloved hand holding a conical flask with blue liquid in a laboratory setting, surrounded by glassware and scientific equipment

Biopharma | March 3, 2025

Continuing Biopharma Growth with U.S. and EU Launch of Ustekinumab Biosimilar

Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union.

Smiling young nurse caregiver supporting mature patient during homecare visit, friendly woman doctor wearing white uniform with stethoscope touching senior man shoulders, psychological help

Biopharma | December 19, 2024

Fresenius to Expand Biopharma Portfolio With a New Licensing Agreement to Commercialize a Proposed Aflibercept Biosimilar

Fresenius, through its operating company Fresenius Kabi, is broadening its growing biopharma portfolio through a new licensing agreement with South Korea’s SamChunDang Pharm (SCD).

Biopharma | September 30, 2024

Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar OtulfiTM* (ustekinumab-aauz)

Otulfi™ received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara®.

Close up of a scientist with protective gloves working with samples in a lab. AI generative

Biopharma | September 27, 2024

Otulfi®*, Fresenius Kabi’s Ustekinumab Biosimilar Developed by Formycon, Receives European Commission Approval

Otulfi® received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab

hand of scientist holding flask with lab glassware in chemical laboratory background, science laboratory research and development concept

Biopharma | July 26, 2024

Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases.

July 25, 2024

Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate

European Medicines Agency has accepted for review the Marketing Authorization Applications for the biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab)

Biopharma | July 1, 2024

Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne® (tocilizumab-aazg) in the United States

The subcutaneous formulation of the tocilizumab biosimilar provides increased access and an affordable treatment option for U.S. patients.

Close Up Of Female Lab Worker Wearing PPE And Safety Glasses Looking At Slide Under Microscope

Biopharma | May 27, 2024

Fresenius Announces U.S. FDA Acceptance for Review of Biologics License Application for Denosumab Biosimilar Candidate

U.S. Food and Drug Administration has accepted for Review of Biologics License Application for our Denosumab Biosimilar Candidate

Young clinician looking at flask with liquid, Young clinician looking at flask with liquid

Biopharma | April 15, 2024

Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®*, its Third Approved Biosimilar in the U.S.

Biopharma | March 18, 2024

Fresenius Kabi and Formycon reach settlement agreement for ustekinumab biosimilar candidate

Fresenius Kabi and Formycon have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara in Europe and Canada.

Biopharma | March 7, 2024

Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) Becomes the First IV and Subcutaneous Tocilizumab Biosimilar Approved by the FDA

Tyenne® becomes Fresenius Kabi's first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA.

Biopharma | November 30, 2023

Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate

Announcement of Fresenius Kabi and its license partner Formycon: FDA has accepted Ustekinumab biosimilar candidate for review.

Biopharma | November 1, 2023

Fresenius Kabi Launches Tyenne®*, the First Approved Tocilizumab Biosimilar in the European Union

Tyenne® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases.

Biopharma | September 29, 2023

Fresenius Kabi and Formycon Announce EMA Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate

Fresenius Kabi and its license partner Formycon AG announce that the European Medicines Agency has accepted the Marketing Authorization Application for FYB202.

Biopharma | September 19, 2023

Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval

Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for its tocilizumab biosimilar Tyenne®.

Biopharma | August 7, 2023

Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar

Fresenius Kabi and Formycon AG entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the U.S.

Biopharma | July 21, 2023

Fresenius Kabi’s Tocilizumab Biosimilar Candidate MSB11456 Receives Positive CHMP Opinion

Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456 receives positive CHMP opinion.

Biopharma | July 12, 2023

Fresenius Kabi’s Denosumab Biosimilar Candidate FKS518 Shows Positive Clinical Trial Results

Fresenius Kabi’ denosumab biosimilar candidate FKS518 shows positive clinical trial results.

Biopharma | July 2, 2023

Fresenius Kabi Launches Its Citrate-Free Biosimilar Idacio® (adalimumab-aacf) In the United States

Fresenius Kabi announced today the launch of its citrate-free biosimilar Idacio (adalimumab-aacf).

Biopharma | February 16, 2023

Fresenius Kabi Launches Biosimilar Stimufend® (pegfilgrastim-fpgk) in the U.S.

Fresenius Kabi announces the launch of pegfilgrastim biosimilar Stimufend® in the U.S., expanding access to quality healthcare solutions against cancer.

Biopharma | February 2, 2023

Fresenius Kabi announces global license agreement with Formycon AG to commercialize proposed Ustekinumab biosimilar

Fresenius Kabi and Formycon partner globally to commercialize Ustekinumab biosimilar, expanding access to affordable healthcare solutions worldwide.

Biopharma | December 14, 2022

Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab)

Fresenius Kabi gets U.S. FDA approval for their biosimilar Idacio®, a citrate-free formulation of adalimumab which use is for chronic autoimmune diseases.

Biopharma | September 6, 2022

Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend® (pegfilgrastim)

Fresenius Kabi announces that the FDA has approved its pegfilgrastim biosimilar, Stimufend® which is a high-quality treatment option for cancer patients.

Biopharma | August 18, 2022

Fresenius Kabi Announces Acceptance of its Marketing Authorization Application by the European Medicines Agency for MSB11456, a Tocilizumab Biosimilar Candidate

Fresenius Kabi announces EMA acceptance for biosimilar MSB11456, which is a new addition to a compelling biosimilar portfolio against autoimmune diseases.

Biopharma | August 10, 2022

Fresenius Kabi Establishes Partnership With Bio-Manguinhos/Fiocruz and Bionovis to Provide Access to Adalimumab Biosimilar in Brazil

Fresenius Kabi announces a partnership with Fiocruz/Bio-Manguinhos for the production of adalimumab biosimilar, IDACIO in Brazil for autoimmune diseases.

Biopharma | August 1, 2022

Fresenius Kabi Completes Majority Stake Acquisition of mAbxience Holding S.L., Significantly Enhancing Presence in High-Growth Biopharmaceuticals Market

Fresenius Kabi's successful majority stake acquisition of mAbxience marks a significant step in their commitment to healthcare innovation and excellence.

Biopharma | August 1, 2022

Fresenius Kabi’s Biologics License Application for Biosimilar Candidate Tocilizumab Accepted for Review by the FDA

The FDA has accepted for review Fresenius Kabi’s Biologics License Application for the company’s biosimilar candidate of tocilizumab.

Press Release | March 31, 2022

Next generation patient care: Fresenius Kabi buys a majority stake in mAbxience and acquires Ivenix

Fresenius Kabi buys a majority stake in mAbxience and acquires Ivenix which significantly enhances their presence in high-growth biopharmaceuticals market.

Biopharma | March 30, 2022

Fresenius Kabi Receives European Commission Approval for Its Pegfilgrastim Biosimilar Stimufend®

Fresenius Kabi announces that the European Commission granted marketing authorization for Stimufend® which offers a high-quality option for cancer patients.

Latest Biosimilars News

Fresenius Receives Positive CHMP Opinion for their Denosumab Biosimilar Candidates

Fresenius receives FDA approval for their Denosumab biosimilars and secures global settlement agreement

Continuing Biopharma Growth with U.S. and EU Launch of Ustekinumab Biosimilar

Fresenius to Expand Biopharma Portfolio With a New Licensing Agreement to Commercialize a Proposed Aflibercept Biosimilar

Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar OtulfiTM* (ustekinumab-aauz)

Otulfi®*, Fresenius Kabi’s Ustekinumab Biosimilar Developed by Formycon, Receives European Commission Approval

Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate

Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate

Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne® (tocilizumab-aazg) in the United States

Fresenius Announces U.S. FDA Acceptance for Review of Biologics License Application for Denosumab Biosimilar Candidate

Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®*, its Third Approved Biosimilar in the U.S.

Fresenius Kabi and Formycon reach settlement agreement for ustekinumab biosimilar candidate

Fresenius Kabi’s Biosimilar Tyenne® (tocilizumab-aazg) Becomes the First IV and Subcutaneous Tocilizumab Biosimilar Approved by the FDA

Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate

Fresenius Kabi Launches Tyenne®*, the First Approved Tocilizumab Biosimilar in the European Union

Fresenius Kabi and Formycon Announce EMA Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate

Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval

Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar

Fresenius Kabi’s Tocilizumab Biosimilar Candidate MSB11456 Receives Positive CHMP Opinion

Fresenius Kabi’s Denosumab Biosimilar Candidate FKS518 Shows Positive Clinical Trial Results

Fresenius Kabi Launches Its Citrate-Free Biosimilar Idacio® (adalimumab-aacf) In the United States

Fresenius Kabi Launches Biosimilar Stimufend® (pegfilgrastim-fpgk) in the U.S.

Fresenius Kabi announces global license agreement with Formycon AG to commercialize proposed Ustekinumab biosimilar

Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab)

Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend® (pegfilgrastim)

Fresenius Kabi Announces Acceptance of its Marketing Authorization Application by the European Medicines Agency for MSB11456, a Tocilizumab Biosimilar Candidate

Fresenius Kabi Establishes Partnership With Bio-Manguinhos/Fiocruz and Bionovis to Provide Access to Adalimumab Biosimilar in Brazil

Fresenius Kabi Completes Majority Stake Acquisition of mAbxience Holding S.L., Significantly Enhancing Presence in High-Growth Biopharmaceuticals Market

Fresenius Kabi’s Biologics License Application for Biosimilar Candidate Tocilizumab Accepted for Review by the FDA

Next generation patient care: Fresenius Kabi buys a majority stake in mAbxience and acquires Ivenix

Fresenius Kabi Receives European Commission Approval for Its Pegfilgrastim Biosimilar Stimufend®