Blog Archives | Page 83 of 101

Recent BioBlast® Updates

Update on First UPC Biosimilar Disputes (Eculizumab and Omalizumab)

Apr 24, 2024

On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC) has become publicly available. The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each...

Samsung Bioepis Reports Year Over Year Revenue Growth of 31%

Apr 24, 2024

Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products. Biosimilar highlights for...

Approval Alert: Samsung Bioepis’ Ustekinumab Biosimilar Pyzchiva® (SB17) Approved in Europe

Apr 22, 2024

On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab). The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the...

Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL

Apr 21, 2024

On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM. The issues identified primarily concern (a) the analytical methods for the reference standard;...

Dr Reddy’s Receives Complete Response Letter for Biosimilar Rituximab in US

Apr 20, 2024

Dr Reddy’s announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for biosimilar rituximab (DRL_RI), biosimilar to Genentech/Biogen’s Rituxan®. The CRL is said to relate to the ongoing resolution of results of regulatory inspections at...

New Indication Alert: MSD’s Keytruda® (pembrolizumab) Approved in Canada for New Gastric Cancer Indication

Apr 19, 2024

On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction...

Alvotech Enters Further US Partnership Agreement for Adalimumab Biosimilar

Apr 19, 2024

On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February...

Approval Alert: Health Canada Approves Nora Pharma’s Niopeg® (peg-filgrastim)

Apr 19, 2024

On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada's approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen's NEULASTA®. This follows Coherus' launch of Udenyca...

NEW INDICATION ALERT – FDA Approves Takeda’s ENTYVIO® (vedolizumab) for Crohn’s Maintenance

Apr 18, 2024

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD). This follows the FDA's acceptance of Takeda's BLA for ENTYVIO® for the...

Celltrion wins Denmark’s national bid for Remsima SC®

Apr 18, 2024

On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®. Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion's Danish subsidiary. This...

Biocon and Biomm Enter Agreement To Supply Generic Ozempic® (semaglutide) in Brazil

Apr 17, 2024

On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil. Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and...

Approval Alert: FDA Approves Alvotech & Teva’s Ustekinumab, Selarsdi™

Apr 16, 2024

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US. This is the second US...