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NEWS

Takeda
Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 
Shots:  The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights  The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…
April 26, 2024
Samsung Bioepis
Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders
Shots:  The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology  The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and  P-III trial assessing the efficacy, safety & PK profile…
April 22, 2024
Immunity Bio
ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC) 
Shots:  ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024  The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…
April 22, 2024
Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US
Shots:  Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US market  The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally  Following commercialization collaboration between…
April 16, 2024
Fresenius Kabi
Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases
Shots:    The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024  Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic…
April 15, 2024
Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications 
Shots:  Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications  As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…
April 4, 2024
Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China 
Shots:  The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment  Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases  The P-I &…
April 3, 2024
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