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Pearce IP BioBlast w/e 09 Feb 2024

by , | Feb 12, 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® (bevacizumab biosimilar) in Australia.  

This comes months after Biocon announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan. 

08 FEB 2024 | CN | Phase III Study Confirms Equivalence of Mabwell’s Denosumab Biosimilar with Amgen’s Xgeva®

A study sponsored by Mabwell (Shanghai) Bioscience Co Ltd and published in JAMA Oncology reports that the results of Chinese randomized, 53-week, phase III trials of Mabwell’s MW032 with Amgen’s Xgeva® in patients with solid tumor-related bone metastases, confirm biosimilarity in efficacy, safety and population pharmacokinetics.   

In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

07 FEB 2024 | KR | Samsung Biologics and LegoChem Biosciences Partner to Develop and Manufacture ADCs

On 7 February 2024, global contract development and manufacturing company Samsung Biologics announced that it has partnered with LegoChem Biosciences for antibody-drug conjugate (ADC) development and manufacturing.  Under the agreement, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem Bioscience’s ADC program designed to treat solid tumours.  LegoChem is aiming to submit an Investigational New Drug (IND) application to the FDA in the first half of 2025.   

Samsung Biologics also reports that it is on track to complete a dedicated ADC facility in South Korea in 2024.  Two weeks ago, Samsung Biologics revealed in its Q4 2024 Earnings its record high operating profit of over ₩1T for 2023. 

07 FEB 2024 | Celltrion to Supply Yuflyma® (infliximab) to Norway

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.  

Celltrion aims to expand further into the Nordic area with plans to enter into Denmark with Remsima SC® sometime in 2024.  

05 FEB 2024 | Rani Therapeutics Releases Encouraging PhI Data for RT-111, Oral Form of Celltrion’s CT-P43 (ustekinumab) Biosimilar 

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial regarding RT-111, a RaniPill® capsule containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The study shows that RT-111 was well-tolerated and delivered ustekinumab with high bioavailability. 

In June 2023, Rani Therapeutics announced that it expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), following their earlier collaboration on ustekinumab (CT-P43). 

05 FEB 2024 | Novartis to Buy MorphoSys AG for €2.7B 

On 5 February 2024, Novartis announced that it has agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B.   Upon completion of the acquisition, notably, Novartis would add to its portfolio the ‘next generation medicines’ of pelabresib which downregulates blood cancer and tulmimetostat used to treat endometrial cancer.

04 FEB 2024 | Rituximab Study Shows Promise for Managing AIBD

A study published in Medicina, on 4 February 2024, concluded that Rituximab represents an efficacious and well-tolerated therapeutic option for the management of Autoimmune Bullous Diseases (AIBD) and warrants consideration in cases of refractory AIBD. 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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