BioPharma BioSimilar

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

Polpharma Biologics Announces FDA File Acceptance for Review of Natalizumab, First Proposed Biosimilar to Tysabri®

The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine, Ty...

 July 26, 2022 | News

Next-generation Diagnostics Paving the Way to Reach Personalized Medicine

New technologies, sequencing methods, novel software algorithms, and multi-omic approaches empower patients to take more active control of their health out...

 June 15, 2022 | News

Biocon Biologics to Acquire Viatris' Biosimilar Assets for Up to US$3.335 Billion in Cash and Equity

Biocon Biologics Ltd., a subsidiary of Biocon Ltd. (BSE: 532523) (NSE: BIOCON), has entered into a definitive agreement with its partner Viatris Inc. (NASD...

 March 03, 2022 | News

Theramex announces an agreement with Enzene Biosciences Limited for the development and commercialisation of Tocilizumab

Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has entered into an agreement with Enzene Biosciences Limit...

 December 24, 2021 | News

Prestige BioPharma and Dr. Reddy’s announce partnership to commercialize trastuzumab biosimilar

Prestige BioPharma Ltd. (KRX: 950210) and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, hereafter referred t...

 December 10, 2021 | News


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