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Recent BioBlast® Updates

Authorities raid Como Compounding Pharmacy in Melbourne and Seize Semaglutide

Mar 1, 2024

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications. As reportedly revealed in a confidential TGA...

First Biosimilar Launch: JAMP Pharma Launches Alvotech-Developed Jamteki™ (ustekinumab) in Canada

Mar 1, 2024

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. Jamteki™ was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding...

UK health regulator issues safety update on Dupixent (dupilumab) side effects

Feb 29, 2024

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects. The regulator warned that side effects can include conjunctivitis and ulcerative keratitis.

Biocon and J&J Ustekinumab Settlement, and Biocon’s US Launch Planned for Feb 2025

Feb 29, 2024

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025. The FDA previously accepted for review Biocon’s...

Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure

Feb 29, 2024

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe. This Xgeva PFS product is a high concentration product which is a line...

Celltrion files Korean Application for CT-P47, Tocilizumab Biosimilar

Feb 28, 2024

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab). The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of...

Celltrion’s Zymfentra® (SC infliximab) launched in US

Feb 28, 2024

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year. Zymfentra® was approved by the FDA in October 2023. Zymfentra® (SC infliximab),...

Akeso Announces Phase 2 Clinical Study Results for Cadonilimab

Feb 27, 2024

On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer. The results were published in the American Association for...

FDA Grants Priority Review of AbbVie’s sBLA for EPKINLY® (epcoritamab SC)

Feb 27, 2024

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL). ...

BeiGene’s BLA for TEVIMBRA® (tislelizumab) Accepted by FDA for Treatment of First-Line Gastric or Gastroesophageal Junction Cancers

Feb 27, 2024

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene's Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date...

CHMP Recommends AZ’s Voydeya® (danicopan) with Ravulizumab or Eculizumab

Feb 26, 2024

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumab or eculizumab for the treatment of adult patients...

CHMP Issues Positive Opinion for BeiGene’s TEVIMBRA® (tislelizumab) for NSCLC

Feb 26, 2024

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung...