Pearce IP BioBlast? for the week ending 20 December 2024
This is the final Pearce IP BioBlast for the year.? The first 2025 edition of BioBlast will be released on 20 January 2025. ?We are pleased to have assisted you to stay current on global biopharma developments throughout 2024, and look forward to supporting you in 2025.
Significant biosimilar activities for?this week?include:
Aflibercept
20 December 2024 |?US | LATAM |?Fresenius &?SamChunDang?Exclusive US & LATAM Licence for?Aflibercept Biosimilar
On 20 December 2024,?Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm?(SCD) to exclusively commercialise?South Korean developed… Read more?here.
Amivantamab?
16 December 2024 | US |?CRL for J&J’s Subcutaneous?Rybrevant? (Amivantamab)
On 16 December 2024,?Johnson & Johnson (J&J) announced that the US FDA issued a Complete Response Letter (CRL) for?its US?Biologics License Application (BLA) for a fixed?subcutaneous…?Read more?here. ?
Concizumab?
21 December 2024 | US |?Approval Alert: Novo Nordisk’s?Alhemo? (Concizumab) Gets US FDA Approval?
On 21 December 2024,?Novo Nordisk announced that the US FDA has approved its Alhemo? (concizumab) injection?as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding… Read more?here.
Donanemab?
17 December 2024 | CN |?Approval Alert:?Eli Lilly’s?Kisunla??(Donanemab) Approved?in China
On 17 December 2024,?Eli Lilly announced that China’s National Medical Products Administration (NMPA) has approved its donanemab-azbt Kisunla??(350 mg/20 mL every four weeks injection for IV… Read more?here.
Dostarlimab?
16 December 2024 | US |?GSK’s?Jemperli? (Dostarlimab) Receives US FDA Breakthrough Therapy Designation
On 16 December 2024,?GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli? (dostarlimab)?for the treatment of patients with locally advanced mismatch… Read more?here.
Golimumab?
16 December 2024 | US |?J&J Submit?sBLA?for Simponi? (Golimumab)
On 16 December 2024,?Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking?the?approval of Simponi? (golimumab)?for… Read more?here.
领英推荐
Nivolumab, Ipilimumab,?Inotuzumab ozogamicin
19 December 2024 | NZ |?New Zealand’s?Pharmac?Seeks Feedback on Funding Proposals for BMS’?Opdivo??&?Yervoy?, and Pfizer’s?Besponsa?
On 19 December 2024,?New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines?for cancer and?antibiotic resistant?infections from 1 April 2025, which includes:… Read more?here.
Olaparib??
11 December 2024 | US |?AstraZeneca and Merck (MSD) Report Positive Phase 3 Results for Olaparib in Early Breast Cancer?
On 11 December 2024,?AstraZeneca and Merck (known as MSD?outside the US and Canada) announced positive results for Lynparza? (olaparib)?in the treatment of breast cancer, as.. Read more?here.
Pertuzumab??
5 December 2024 | IN |?CDSCO Panel Approves Zydus’ Safety Study of Pertuzumab Biosimilar
At a meeting on 5 December 2024,?the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO)?approved Zydus’ Sigrima?,?biosimilar to Roche’s... Read more?here. ?
Sacituzumab govitecan??
17 December 2024 | US |?Gilead’s?Trodelvy??(Sacituzumab?Govitecan-hziy)?Granted FDA?Breakthrough Therapy Designation
On 17 December 2024,?Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy? (sacituzumab govitecan-hziy)?for the treatment of adult… Read more?here.
Ustekinumab
15-17 December 2024 | EU | US |?Approval Alerts: Accord and Celltrion’s Ustekinumab Biosimilars Approved in EU and US, Biocon Receives EU Recommendation
On 15 December 2024, ?Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of… Read more?here.
20 November 2024 | CA |?JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara? (Ustekinumab)
We reported on 26 August 2024 that?JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara?… Read more?here.
PBAC News??
20 December 2024 | AU |?Australia’s PBAC Recommends?Sandoz’s?Denosumab and Celltrion’s Ustekinumab Biosimilars Among November Outcomes
On 20 December?2024, Australia’s?Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes?considered at its?November?2024 meeting, recommending listing for one biosimilar,… Read more?here.
18 December 2024 | AU |?Originators Dominate PBAC’s May 2025 Agenda
On 18 December 2024,?Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting… Read more?here. ?