Blog Archives | Page 93 of 101

Recent BioBlast® Updates

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.

Novartis’s Cosentyx® (secukinumab) Approved by Scottish Medicines Consortium (SMC) for Treatment of Active Moderate to Severe Hidradenitis Suppurativa (HS)

Feb 12, 2024

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional...

Health Canada Approves MSD’s KEYTRUDA® (pembrolizumab) in Combination with Trastuzumab and Chemotherapy as Treatment for Adenocarcinoma Patients

Feb 12, 2024

On 12 February 2024, MSD, announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or...

Biogen Receives European Commission’s Approval for SKYCLARYS® (omaveloxolone) to Treat Friedreich’s Ataxia

Feb 12, 2024

On 12 February 2024, Biogen announced that the European Commission approved its SKYCLARYS® (omaveloxolone) on 9 February 2024. SKYCLARYS® was approved for treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. The announcement...

Biocon Biologics Enter a Five-year Exclusive Partnership with Sandoz in Australia for Trastuzumab and Bevacizumab Biosimilars

Feb 9, 2024

On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive partnership agreement with Sandoz AG. The agreement provides Sandoz AG the right to promote, sell and distribute Biocon’s OGIVRI® (trastuzumab biosimilar) and ABEVMY®...

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Recent BioBlast® Updates

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

Novartis’s Cosentyx® (secukinumab) Approved by Scottish Medicines Consortium (SMC) for Treatment of Active Moderate to Severe Hidradenitis Suppurativa (HS)

Health Canada Approves MSD’s KEYTRUDA® (pembrolizumab) in Combination with Trastuzumab and Chemotherapy as Treatment for Adenocarcinoma Patients

Biogen Receives European Commission’s Approval for SKYCLARYS® (omaveloxolone) to Treat Friedreich’s Ataxia

Biocon Biologics Enter a Five-year Exclusive Partnership with Sandoz in Australia for Trastuzumab and Bevacizumab Biosimilars

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