Recent BioBlast® Updates

FDA Issues Second Complete Response Letter to Outlook Therapeutics for Ophthalmic Bevacizumab

Aug 28, 2025

On 28 August 2025, Outlook Therapeutics announced that the US FDA issued a complete response letter (CRL) declining its BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™

Bayer’s Eylea® 8mg PFS (OcuClick) Approved in Korea

Aug 28, 2025

On 28 August 2025, Bayer announced that it has received approval from Korea’s Ministry of Food and Drug Safety for its OcuClick pre-filled syringe (PFS) presentation of Eylea® 8mg (aflibercept). The

Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved

Aug 26, 2025

On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The

CuraTeQ’s Trastuzumab Biosimilar UK Approved

Aug 26, 2025

On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to

Abbott’s Denosumab Biosimilar First to be Approved in Thailand

Aug 26, 2025

On 26 August 2025, Abbott announced that it has secured regulatory approval for the first denosumab biosimilar, referencing Amgen’s Prolia®/Xgeva®, in Thailand.

Bio-Thera & STADA Extend Partnership to Biosimilar Tocilizumab

Aug 25, 2025

On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab. Under the agreement, Bio-Thera will maintain

New Indication Alert: Opdivo®/Yervoy® Combo Approved in Japan for MSI-High CRC

Aug 25, 2025

On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy

PBAC Refuses MSD’s Proposal for Broad Keytruda® PBS Listing

Aug 22, 2025

At its July 2025 meeting, Australia’s Pharmaceutical Benefits and Advisory Committee (PBAC) rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in

Australia’s PBAC Recommends Reimbursement of Sandoz, Biocon and Celltrion Biosimilars to Aflibercept, Etanercept and Infliximab (Respectively)

Aug 22, 2025

On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on

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Recent BioBlast® Updates

FDA Issues Second Complete Response Letter to Outlook Therapeutics for Ophthalmic Bevacizumab

Bayer’s Eylea® 8mg PFS (OcuClick) Approved in Korea

Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved

CuraTeQ’s Trastuzumab Biosimilar UK Approved

Abbott’s Denosumab Biosimilar First to be Approved in Thailand

Bio-Thera & STADA Extend Partnership to Biosimilar Tocilizumab

New Indication Alert: Opdivo®/Yervoy® Combo Approved in Japan for MSI-High CRC

PBAC Refuses MSD’s Proposal for Broad Keytruda® PBS Listing

Australia’s PBAC Recommends Reimbursement of Sandoz, Biocon and Celltrion Biosimilars to Aflibercept, Etanercept and Infliximab (Respectively)

BIOCAD Obtains Approval of First Daratumumab Biosimilar

Pfizer’s IV Infliximab Biosimilar Approved in NZ

BioDlink’s Biosimilar Bevacizumab Approved in Indonesia, Pakistan and Columbia

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