NEWS

The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC)

Shots: The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3%…

June 26, 2024

The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19

Shots: The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19 The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…

June 24, 2024

Botanix Pharmaceuticals’ Sofdra (Sofpironium) Receives the US FDA’s Approval to Treat Primary Axillary Hyperhidrosis

Shots: The US FDA has granted approval to Sofdra gel (12.45%) for the treatment of adults & children (≥9yrs.) with primary axillary hyperhidrosis The approval was based on the two pivotal P-III (CARDIGAN) trials assessing the efficacy & safety of Sofdra vs vehicle in primary axillary hyperhidrosis patients (n=701). Trials reached its 1EPs & 2EPs…

June 20, 2024

Alvotech and Advanz Pharma Team Up to Commercialize AVT06/AVT29 (Biosimilar, Eylea) in Europe

Shots: Alvotech has signed an exclusive partnership agreement with Advanz Pharma to supply and commercialize AVT06 (2mg, Low dose) and AVT29 (8mg, High dose), biosimilars of Eylea As per the agreement, Alvotech will develop & supply the biosimilars and receive an upfront plus subsequent development & commercialization milestones. Advanz Pharma will handle registration &…

June 18, 2024

Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab)

Shots: Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the…

June 11, 2024

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

Shots: The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…

June 10, 2024

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia

Shots: The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA) The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks.…

June 6, 2024

AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer

Shots: The CHMP’s positive opinion of Tagrisso + pemetrexed & Pt-based CT as a 1L treatment of locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC with exon 19 deletions or exon 21 (L858R) mutations was based on P-III (FLAURA2) study The P-III (FLAURA2) study assessed Tagrisso (80mg, oral, QD) + CT [pemetrexed…

June 3, 2024

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

Shots: The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi…

June 3, 2024

CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

Shots: The CHMP has granted positive opinion to Cejemly (sugemalimab) + CT as a 1L treatment of metastatic NSCLC The positive opinion was supported by the P-III (GEMSTONE-302) study, demonstrating improvement in PFS & OS with sugemalimab + CT vs PBO + CT among treatment-naïve stage IV NSCLC patients. Results were published in The…

June 1, 2024