No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Jan 17, 2024
On 17 January 2024 Samsung Bioepis released its fourth US Biosimilar Market Report. The quarterly report details recent prices of US-launched biosimilars, and market share and price trends. The report covers the US-approved biosimilars on 14 INNs, of which 45 have...
Jan 17, 2024
Business Korea reported that Celltrion launched its 80mg dose of Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in the US on 17 January 2024. It is the same high-concentration (100mg/mL) formulation as the 40mg dosage form already available in the US. ...
Jan 17, 2024
The Hindu reported that Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for marketing authorisation for its trastuzumab (biosimilar to Genentech’s Herceptin®) from India’s Subject Experts Committee of the Central Drugs Standard Control...
Jan 16, 2024
A study evaluating results from a Phase 3, randomised, double blind trial sponsored by Samsung Bioepis was published on 16 January 2023 in the journal, Frontiers in Pharmacology. The results show that Samsung Bioepis’ SB8 (bevacizumab biosimilar) had a comparable...
Jan 16, 2024
Roche announced that the European Commission (EC) has granted it marketing authorisation for Tecentriq® SC (atezolizumab) for subcutaneous injection. The new authorisation applies to all indications already approved for the previous formulation of Tecentriq®...
Jan 16, 2024
Regeneron and Sanofi announced that the FDA has updated the Dupixent® (dupilumab) label to include efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. The new data has...
Jan 15, 2024
Korea Biomed has reported that Samsung Bioepis will stop supplying the low concentration formulations of Adalloce®, biosimilar to AbbVie’s Humira® (adalimumab), in Korea. Samsung Bioepis will continue to supply Adalloce® in two high-concentration formulations:...
Jan 15, 2024
Korea Biomed has reported that LG Chem plans to launch Xelenka®, its biosimilar to AbbVie’s Humira® (adalimumab), in Korea in the second half of 2024, despite obtaining approval from the Korean Ministry of Food and Drug Safety on 15 December 2023. The report states...
Jan 15, 2024
Boan Biotech announced that it has completed enrolment for the international multi-centre comparative clinical phase III study of BA6101 and BA11021, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively. The studies are being conducted simultaneously...
Jan 15, 2024
Biospectrum India reported that Indian-based Enzene Biosciences announced its plans to establish a continuous manufacturing site in Hopewell, New Jersey. Enzene intends the manufacturing site to be operational in June 2024. Enzene also announced its plans to...
Jan 12, 2024
Korea Biomedical Review reported that Celltrion has won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) in Friuli-Venezia Giulia (FVG) and Sicily in Italy, as well as in the south eastern region of Netherlands. Celltrion will supply Yuflyma® for...
Jan 12, 2024
MSD announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. On 15 December 2023, Keytruda® in...
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.