BioBlast w/e 04 Aug 23

by , | Aug 7, 2023

Teva’s CEO confirmed that it will still pursue launching its Alvotech developed adalimumab biosimilar of AbbVie’s Humira® (adalimumab) next year despite seven biosimilars launching in the US on 1 July 2023, and Amgen launching Amjevita® on 31 January 2023.  Teva’s CEO, Richard Francis noted that “it’s always going to be a challenging market but I do see it’s worth the effort for 2024.”

On 24 July 2023, Teva and Alvotech announced they agreed to expand their existing strategic partnership agreement for the US, which already included development of AVT02 (adalimumab).

Astellas announced that China’s National Medical Products Administration (NMPA) has accepted its Biologics License Application (BLA) for zolbetuximab as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.  The BLA was based on phase III clinical trials which evaluated zolbetuximab with a combination chemotherapy regimen that included capecitabine and oxaliplatin.

Samsung Bioepis and Organon announced the topline results for their interchangeability study for SB5 (Hadlima®), a biosimilar to AbbVie’s Humira® (adalimumab).  The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) was in patients with moderate to severe chronic plaque psoriasis.  The study found that efficacy profiles, safety profiles and immunogenicity were comparable between patients who received Hadlima® and those who received Humira®.

SB5 was first approved by the FDA on 24 July 2019; and was launched in the US on 1 July 2023 at a list price of $1038, an 85% discount compared to Humira®.

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab) OSIP refused the application as the ‘837 patent application was filed in Canada after the submissions.

Health Canada approved ulcerative colitis as an indication for Stelara® on 27 January 2020.

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 the pharma/biopharma industries, resulting from 25 years' experience including as VP of IP in-house global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

Sian Hope

Sian Hope

Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.
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