Blog Archives | Page 100 of 101

Recent BioBlast® Updates

AGC Biologics to Build New Biologics and ATMP Manufacturing Site in Yokohama

Jan 4, 2024

AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy medicinal products (ATMPs) in Yokohama Japan. It expects the site to be operational in 2026. The 20,000 m² facility will offer pre-clinical through to...

Accord’s BLA for its Ustekinumab (Stelara®) Biosimilar Accepted by FDA; Settlement with Janssen Permits Launch by 15 May 2025

Jan 4, 2024

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®. DMB-3115 was jointly...

Samsung Bioepis, Celltrion and Formycon File Opposition to Regeneron Motion for Alternative Service in Eylea® (aflibercept) Proceedings

Jan 4, 2024

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea®...

First Biosimilar Alert: Glenmark Launches Lirafit®, the First Liraglutide Biosimilar Launched in India

Jan 3, 2024

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India. Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product. ...

Alexion Sues Samsung Bioepis over SB12 Biosimilar to Soliris® (eculizumab)

Jan 3, 2024

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents. The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA) for SB12, its biosimilar to...

Alvotech Reports Positive Top-line Results from Study on AVT06, Biosimilar to Regeneron’s Eylea® (aflibercept)

Jan 3, 2024

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept). The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of...

Coherus Launches Loqtorzi® (toripalimab-tpzi) in the US

Jan 2, 2024

Coherus Biosciences announced that it has launched Loqtorzi® (toripalimab-tpzi) in the US. It was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine to treat adults with metastatic or recurrent locally advanced nasopharyngeal...

Approval Alert: AstraZeneca/Sanofi’s Beyfortus® (nirsevimab) to Prevent RSV LRTD Approved by NMPA

Jan 2, 2024

AstraZeneca and Sanofi announced that Beyfortus® (nirsevimab) has been approved by the National Medical Products Administration (NMPA) in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants...

EMA Validates BMS’s MA for repotrectinib

Jan 2, 2024

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib. BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult...

Biosimilar PBS Listing: Cipla’s Adalicip® Biosimilar to AbbVie’s Humira® PBS-Listed

Jan 1, 2024

Cipla’s Adalicip®, developed by Alvotech (AVT02), biosimilar to AbbVie’s Humira® (adalimumab) has been listed on the PBS (General Pharmaceutical Benefits) in the 40mg/0.4mL dosage in syringes and pen devices. It is reimbursed to treat various conditions, including...

MHRA’s New International Recognition Procedure (IRP) Launches

Jan 1, 2024

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new International Recognition Procedure (IRP), allowing medicine developers to now submit applications. The IRP replaces the EC Decision Reliance Procedure after the UK left the EU...

Regeneron Sues Samsung Bioepis over Biosimilar to Eylea® (aflibercept)

Dec 27, 2023

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement. This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first...

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.

Subscribe here

PEARCE IP BLOG

Read our latest updates & insights

No Results Found

Recent BioBlast® Updates

AGC Biologics to Build New Biologics and ATMP Manufacturing Site in Yokohama

Accord’s BLA for its Ustekinumab (Stelara®) Biosimilar Accepted by FDA; Settlement with Janssen Permits Launch by 15 May 2025

Samsung Bioepis, Celltrion and Formycon File Opposition to Regeneron Motion for Alternative Service in Eylea® (aflibercept) Proceedings

First Biosimilar Alert: Glenmark Launches Lirafit®, the First Liraglutide Biosimilar Launched in India

Alexion Sues Samsung Bioepis over SB12 Biosimilar to Soliris® (eculizumab)

Alvotech Reports Positive Top-line Results from Study on AVT06, Biosimilar to Regeneron’s Eylea® (aflibercept)

Coherus Launches Loqtorzi® (toripalimab-tpzi) in the US

Approval Alert: AstraZeneca/Sanofi’s Beyfortus® (nirsevimab) to Prevent RSV LRTD Approved by NMPA

EMA Validates BMS’s MA for repotrectinib

Biosimilar PBS Listing: Cipla’s Adalicip® Biosimilar to AbbVie’s Humira® PBS-Listed

MHRA’s New International Recognition Procedure (IRP) Launches

Regeneron Sues Samsung Bioepis over Biosimilar to Eylea® (aflibercept)

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Sign up to receive the latest life sciences industry news