Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Pearce IP BioBlast w/e 26 Jan 2024

by | Jan 29, 2024

26 JAN 2024 | SG | AbbVie to Expand Biologics Manufacturing Facility in Singapore with US$223M Investment

AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore.  The investment will add 24,000L of biologics drug-substance capacity to AbbVie’s manufacturing network.  The expansion intends to support current products and emerging immunology and oncology compounds.  Construction will begin later in 2024, with operations expected to commence in 2026.

Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE).  Dupixent® is the first and only medicine approved in the US to treat these patients.  It was approved to treat EoE patients 12 years and older in May 2022.

On 6 May 2023, a Regeneron-sponsored study concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of EoE.

Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion Korean won) annual revenue in 2023 for the first time in the company’s history.  This was due to the 8% growth in revenue from new product launches and sales expansion.

Parent company Samsung Biologics’ operating profit of over ₩1T was also a record high.  On 25 October 2023, Samsung Biologics reported its highest ever quarterly consolidated revenue of over ₩1T.

The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab).  It is indicated to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Onbevzi® is marketed by Samsung Bioepis as Aybintio® in Europe, which was approved by the European Commission on 20 August 2020.

Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review.

On 19 January 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Bayer’s Eylea® 8mg to treat nAMD and visual impairment due to diabetic macular oedema (DMO).

WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).  Under the agreement, WuXi will be Celltrion’s primary service provider for its projects, including from process development to GMP manufacturing.

On 11 January 2024, WuXi XDC’s parent company WuXi Biologics signed a $20M research service agreement with BioNTech to develop two monoclonal antibody therapeutics.

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential resubmission of its biologics license application (BLA) by the end of 2024.  Outlook has also entered into securities purchase agreements for up to $172M to fund the advancement of ONS-5010.

Outlook submitted its SPA request to the FDA regarding the design of the study on 19 December 2023.

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursement talent and access to proprietary commercial software.  Closing is anticipated in the first half of 2024, subject to standard conditions and approvals.

Coherus announced its sales of Cimerli® surpassed 100,000 doses in its first year in the US following launch in October 2022.

PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety.  Episcli® is approved to treat nocturnal hemoglobinuria.

On 3 January 2024 Alexion sued Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six of its eculizumab patents.

The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s Stelara® (ustekinumab), in Australia.  The vial and pre-filled syringe for subcutaneous injection have been approved to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease (CD) and ulcerative colitis (UC).  The vial for IV infusion is indicated for CD and UC.

The FDA approved Wezlana® as the first biosimilar to Stelara® on 31 October 2023.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced life sciences patent lawyer, providing IP leadership for product development and commercialisation across global markets in pharmaceuticals, biopharmaceuticals, medical technology and devices, digital health and diagnostics – from initial scoping through to post-launch. She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

Sian Hope

Sian Hope

Lawyer

Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.

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.

Our Latest News