BioPharma BioSimilar

Celltrion Celebrates a Decade of Biosimilar Innovation in Europe

Marking 10 years since the European Medicines Agency (EMA) approved the world’s first monoclonal antibody biosimilar infliximab, for all indication...

 September 11, 2023 | News

Biocon Biologics Expands Global Presence, Completes Viatris Biosimilars Integration in North America Ahead of Schedule.

To further strengthen its leadership position in the global biosimilars industry and provide complete end-to-end capabilities to patients and customers, Bi...

 September 07, 2023 | News

Transcenta's Anti-sclerostin Antibody TST002 Approved for Phase II Trial in China for Reduced Bone Density Patients

This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in p...

 July 31, 2023 | News

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate D...

 July 14, 2023 | News

C2 PHARMA Receives Approval for Digoxin China DMF, Becoming China’s Only European Supplier of This API

 C2 Pharma the global leader in manufacturing and supplying ophthalmic and niche active pharmaceutical ingredients (APIs), proudly announces the appro...

 June 14, 2023 | News

EirGenix's Breast Cancer Biosimilar EG1206A Meets Phase 1 Trial Goals

Comparing EG1206A to Roche's Perjeta® US and EU, results of the clinical data analysis show that the main test indicators have met the pharmacokinetics...

 May 08, 2023 | News

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested u...

 April 21, 2023 | News

Mabwell's Biosimilar Denosumab solution approved by NMPA for osteoporosis treatment

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that the Denosumab solution for injection (...

 April 04, 2023 | News

Biosimilars Revolutionizing Healthcare in Asia Pacific: A Promising Future Ahead

These products are biologic drugs that are highly similar to an already approved reference biologic drug and are designed to provide cost-effective alterna...

 February 23, 2023 | News

Amjevita™ (Adalimumab-atto), First Biosimilar to Humira®, Now Available in the United States

Amgen (NASDAQ:AMGN)  announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the Un...

 February 01, 2023 | News

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a g...

 January 23, 2023 | News

China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Actemra® (Tocilizumab)

Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NM...

 January 18, 2023 | News

Cambrex to Acquire Snapdragon Chemistry, a Leader in Continuous Flow API Development Services

Snapdragon specializes in active pharmaceutical ingredient (API) batch and continuous flow process development, utilizing state-of-the-art automation techn...

 November 22, 2022 | News

New Cardinal Health research highlights rheumatologists' increasing confidence in biosimilars

The research revealed that rheumatologists are both more familiar with biosimilars and more comfortable prescribing them than they were in 2020, just in ti...

 October 20, 2022 | News


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