On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL)...
New Indication Alert: MSD’s Keytruda® (pembrolizumab) Approved in Canada for New Gastric Cancer Indication
On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda®...
Alvotech Enters Further US Partnership Agreement for Adalimumab Biosimilar
On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to...
NEW INDICATION ALERT – FDA Approves Takeda’s ENTYVIO® (vedolizumab) for Crohn’s Maintenance
On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for...
Celltrion wins Denmark’s national bid for Remsima SC®
On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous...
Biocon and Biomm Enter Agreement To Supply Generic Ozempic® (semaglutide) in Brazil
On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic®...
Approval Alert: FDA Approves Alvotech & Teva’s Ustekinumab, Selarsdi™
On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to...
New Indication Alert: MSD’s Keytruda® Obtains Approval for Cervical Cancer Indication in Korea
The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained...
Fresenius Launches Biosimilar Tocilizumab in the US
On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra®...
Celltrion Presents Phase 3 Results for Denosumab Biosimilar
The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to...
Aflibercept Appeals Dismissed for Lack of Jurisdiction
As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for...
Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia
On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement...
Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar
On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17),...
Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland
On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab) biosimilar FYB201 in...
Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)
On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for...
Ginkgo Bioworks to Improve Novo Nordisk’s Chronic Disease Medications Manufacturing Over 5 Years
Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader,...