Pearce IP BioBlast? for the week ending 24 January 2025

Afilbercept?

20 January 2025 | EU |?New Approval Alert: Formycon’s Aflibercept Biosimilar Approved in Europe

On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive?/Baiama? (aflibercept), biosimilar to Regeneron/Bayer’s Eylea?, has been granted marketing approval?...?Read more?here.?

15 January 2025 | US |?Celltrion Challenges Regeneron’s US Aflibercept Formulation Patent in IPR Filing

On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea? ... Read more?here.

Amivantamab

16 January 2025 | CA |?New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

On 16 January 2025, Johnson & Johnson (J&J) announced that?Health Canada has approved its Rybrevant? (amivantamab for injection) in combination with standard of care chemotherapy?… Read more?here.

Bimekizumab

16 January 2025 | US |?UCB Launches High Dose Bimekizumab in the US

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx? (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector... Read more?here.

Daratumumab

22 January 2025 |?J&J Reports Q4 2024 Results; Annual Darzalex? Sales Total USD11.7B

On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.?On the same day, Genmab announced that worldwide?... Read more?here.

Denosumab

24 January 2025 | US |?Amgen and Celltrion Settle US Denosumab Litigation

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey ... Read more?here. ?

20 January 2025 | US | EU | JP |?Celltrion Plans 2025 US/EU/JP Launch of Biosimilar Denosumab at Significant Discount for Osteoporosis Prevention

On 20 January 2025,?Korea Biomedical Review?reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its?plans to launch CT-P41 ... Read more?here.

Faricimab

20 January 2025 | CA |?Health Canada Approves Roche’s Vabysmo? PFS

On 20 January 2025, Roche announced that?Health Canada has approved its Vabysmo? (faricimab) 6.0 mg single-use pre-filled syringe (PFS)?for use in the treatment of nAMD ... Read more?here.?

Garadacimab

24 January 2025 | AU |?Australia’s TGA Approves CSL’s Garadacimab in World First

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry? (garadacimab) for routine prevention of recurrent hereditary … Read more?here.

Goliumumab

27 January 2025 | US |?Alvotech/Teva’s BLAs for Biosimilar Golimumab First to be Accepted by FDA

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi? … Read more?here.

Isatuximab

22 January 2025 | EU |?New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma?

On 22 January 2025, Sanofi announced that the?European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa? (isatuximab)?... Read more?here.

Lecanemab

27 January 2025 | US |?FDA Approves Eisai/Biogen’s Leqembi? IV Maintenance Dosing for Early Alzheimer’s Disease

On 26 and 27 January 2025,?Eisai?and?Biogen?announced that?the US FDA has approved Leqembi? (lecanemab-irmb) IV maintenance dosing?for the treatment of Alzheimer's?… Read more?here.

Tocilizumab?

15 January 2025 |?Positive Topline Results for Ph 1 & 3 Studies of Mochida/Richter’s Tocilizumab Biosimilar

On 15 January 2025,?Gedeon Richter?and?Mochida Pharmaceutical Co. announced?positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19, biosimilar to Roche’s?...?Read more?here.

Toripalimab?

17 January 2025?| AU |?Approval Alert: Junshi Biosciences/Dr Reddy’s Tuoyi? (Toripalimab) Approved in Australia

On 17 January 2025, Junshi Biosciences announced that?Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi? (toripalimab)?for the treatment of adults?… Read more?here.

Ustekinumab

23 January 2025 | EU |?Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma?/CT-P43, biosimilar to J&J/Janssen’s Stelara? (ustekinumab), in France, Italy, Spain, the UK, and Germany … Read more?here. ?

16 January 2025 | US |?Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila

On 16 January 2025,?AIS Health?reported that Amgen has launched Wezlana? (ustekinumab), biosimilar to J&J/Janssen’s Stelara? in the US through Optum Health Solution’s ... Read more?here.

Company News??

22 January 2025 |?Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), … Read more?here.