Skip to content Skip to footer
Subscribe Now
Celltrion
NEWS

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications  

Shots:   The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)   Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…
February 24, 2024

Read more

Vertex Pharmaceuticals
NEWS

Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants  

Shots:   The company received the CHMP’s positive opinion for the label expansion of Kalydeco (Ivacaftor) to include the treatment of infants (aged 1mos.-4mos.) with cystic fibrosis with specific mutations in the CFTR gene (R117H/G551D/G1244E/G1349D/G178R/G551S/S1251N/S1255P/S549N/S549R)  Kalydeco has been approved by the EU for the treatment of cystic fibrosis patients aged ≥4mos. with specific CFTR gene mutations …
February 23, 2024

Read more

NEWS

Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots:  The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease  The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…
February 23, 2024

Read more

NEWS

CSL Vifor and Travere Therapeutics’ Filspari (sparsentan) Gains CHMP’s Positive Opinion to Treat IgA Nephropathy  

Shots:   The CHMP has granted positive opinion to CSL (exclusive commercialization rights holder in the EU, Australia & New Zealand) & Travere’s sparsentan for its conditional approval to treat primary IgAN with a urine protein excretion >1.0 g/day. EC’s decision is anticipated in Q2’24  The opinion was supported by the P-III (PROTECT) trial investigating the…
February 23, 2024

Read more

NEWS

Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS) 

Shots:   The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…
February 23, 2024

Read more

Samsung Bioepis
NEWS

Samsung Bioepis Highlights 2 Abstracts for SB17 (biosimilar, ustekinumab) for the Treatment of Moderate-to-Severe Psoriasis at ECCO 2024  

Shots:    The first study highlights the results from the analytical assessment of the safety & efficacy of SB17 vs Stelara (ustekinumab) which demonstrated SB17 to be biologically similar to Stelara in terms of its physicochemical, structural & biological attributes   Additionally, the data supports the similarity of SB17 with reference Stelara in terms of the biosimilarity, PK,…
February 22, 2024

Read more

Celltrion
NEWS

Celltrion Presents the Long-Term Data for CT-P13 (biosimilar, infliximab) to Treat Inflammatory Bowel Disease (IBD) at ECCO 2024 

Shots:  The company presented 2yrs. results from the P-III (LIBERTY-CD) & (LIBERTY-UC) trial evaluating the superiority in safety & efficacy of CT-P13 (SC) vs Remicade in patients (n=180 & 237) with moderately to severely active CD & UC   In the trials, 85.6% & 87% of patients completed the extension phase with clinical remission, clinical response,…
February 21, 2024

Read more

Samsung Bioepis
NEWS

Samsung Bioepis Reports the Initiation of the P-I Trial Evaluation of SB27 (biosimilar, pembrolizumab) for the Treatment of Lung Cancer

Shots:  The company received the MHLW’s approval to initiate a P-I clinical trial for the bioequivalence evaluation of SB27 as compared to Keytruda (pembrolizumab)  The P-I clinical trial evaluates the safety, efficacy & immunogenicity of SB27 vs Keytruda in patients with Stage II-IIIA NSCLC following complete resection & adjuvant Platinum-based CT  Keytruda is a PD-1-blocking…
February 21, 2024

Read more

NEWS

Coherus BioSciences Launches an On Body Injector for the Administration of Udenyca (biosimiolar, pegfilgrastim) to Treat Non-Myeloid Malignancies

Shots:   The US FDA approved Udenyca Onbody earlier in Dec 2023, as an OBI device to administer Udenyca, a biosimilar of pegfilgrastim. The company has launched Udenyca in the US market for the treatment of patients with non-myeloid malignancies    Udencya is a leukocyte growth factor indicated to be administered the day after CT to lower the rate…
February 21, 2024

Read more

Sandoz
NEWS

Sandoz’s Jubbonti (biosimilar, denosumab) Receives Health Canada’s Approval for the Treatment of Osteoporosis

Shots:   Health Canada has approved the Jubbonti subcutaneous injection to treat osteoporosis and increase bone mass. The approval is based on the results of Phase I and Phase III clinical studies results that show Jubbonti has the same safety and risk as the reference medicine (Prolia)   This human mAb and ligand inhibitor (bone metabolism regulator)…
February 20, 2024

Read more

Load more