Recent BioBlast® Updates

March a Bumper Month for Biopharma at the Pharmaceutical Benefits Assessment Committee (PBAC) in Australia

Feb 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement. The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following:

Celltrion Wins Peru Tenders for Adalimumab, Trastuzumab & Rituximab Biosimilars

Feb 19, 2024

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab). These contracts...

New Indication Alert: FDA Approves Genentech’s Xolair® (omalizumab) for Treatment of Food Allergies

Feb 16, 2024

Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. The announcement states that Xolair® is the first FDA-approved...

New Indication Alert: Japan’s MHLW grants approval for Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria

Feb 16, 2024

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy. Approval followed...

Alvotech Announces Settlement and Launch Dates for Ustekinumab Biosimilar in Europe, Japan and Canada

Feb 15, 2024

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions. AVT04 received regulatory approval...

FDA Grants Priority Review for BMS’s Augtyro® (repotrectinib)

Feb 14, 2024

BMS announced that the FDA has accepted a priority review for its Augtyro® (repotrectinib) for the treatment of patients 12 years of age and older with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or...

FDA and EMA Accept Galderma’s Regulatory Filings for Nemolizumab in Patients with Prurigo Nodularis and Atopic Dermatitis

Feb 14, 2024

On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications, and the EMA accepted its Marketing Authorization Applications, for use of nemolizumab in the treatment of patients with prurigo nodularis and atopic dermatitis. Galderma...

Celltrion Submits Application for Tocilizumab Biosimilar

Feb 13, 2024

On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, biosimilar to Actemra® (tocilizumab). This follows the announcement by Celltrion at the end of...

Qilu’s Aflibercept Biosimilar Equivalent to Regeneron’s Eylea® for nAMD

Feb 13, 2024

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar...

Phase III Study Demonstrates Biosimilarity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab)

Feb 13, 2024

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab). ...

Genentech and Partners File Motion to Dismiss their IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)

Feb 12, 2024

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579. The motion records that Celltrion (the petitioner)...

Takeda’s EOHILIA ® (budesonide oral suspension) Approved by FDA

Feb 12, 2024

Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE). Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.

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Recent BioBlast® Updates

March a Bumper Month for Biopharma at the Pharmaceutical Benefits Assessment Committee (PBAC) in Australia

Celltrion Wins Peru Tenders for Adalimumab, Trastuzumab & Rituximab Biosimilars

New Indication Alert: FDA Approves Genentech’s Xolair® (omalizumab) for Treatment of Food Allergies

New Indication Alert: Japan’s MHLW grants approval for Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria

Alvotech Announces Settlement and Launch Dates for Ustekinumab Biosimilar in Europe, Japan and Canada

FDA Grants Priority Review for BMS’s Augtyro® (repotrectinib)

FDA and EMA Accept Galderma’s Regulatory Filings for Nemolizumab in Patients with Prurigo Nodularis and Atopic Dermatitis

Celltrion Submits Application for Tocilizumab Biosimilar

Qilu’s Aflibercept Biosimilar Equivalent to Regeneron’s Eylea® for nAMD

Phase III Study Demonstrates Biosimilarity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab)

Genentech and Partners File Motion to Dismiss their IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)

Takeda’s EOHILIA ® (budesonide oral suspension) Approved by FDA

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