On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of at least two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative colitis. Samsung Bioepis informed the Court that it has applied for regulatory approval of its biosimilar referencing Stelara® and is expecting PBS (reimbursement) approval in July/August 2025. The Court has provisionally scheduled a trial for 18 – 22 November 2024.
On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.
Once-weekly Awiqli® dosing demonstrated superior blood sugar reduction and time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients. For those not previously treated with insulin, rates of clinically significant or severe hypoglycemia were low. In type 1 diabetes patients, Awiqli® was non-inferior in reducing HbA1c but showed a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec. The drug appeared safe and well-tolerated across the program.
Novo Nordisk anticipates final marketing authorisation from the European Commission in the coming months.
This news comes soon after Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events.
This news also follows on the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.
On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting. CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:
- Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, for all indications of Amgen’s Prolia® and Xgeva® respectively. Jubbonti® and Wyost® were approved in the US on 5 March 2024.
- Celltrion’s Omlyclo® (omalizumab), biosimilar to Novartis’ Xolair®. Celltrion submitted an A-BLA in the US for its omalizumab bioximilar (CT-P39) earlier this month.
Other positive opinions adopted by CHMP include:
- Outlook Therapeutics’ LytenavaTM (bevacizumab-vikg) for wet AMD. If approved, LytenavaTM will be the first available on-label ophthalmic formulation of bevacizumab in the EU (or US).
- Novo Nordisk’s diabetes treatment, Awiqli® (insulin icodec), a long-acting basal insulin given subcutaneously once a week.
An indication extension was recommended for UCB’s previously EU-approved Bimzelx® (bimekizumab) for the treatment of hidradenitis suppurativa.
On 22 March 2024, Korea Biomedical Review reported Geo-Young, South Korea’s largest pharmaceutical distributor, signing a third-party logistics (3PL) contract with Samsung Bioepis for the distribution of biosimilar medicines within South Korea. This is the first business agreement between the two companies in which Geo-Young will carry out the entire distribution process from warehousing to storage and shipping. Geo-Young will distribute Samsung Bioepis biosimilar products to general hospitals nationwide.
On 20 March, 2024, BMS announced that its CAR-T cell immunotherapy Abecma ®(idecabtagene vicleucel) was granted an extension of its therapeutic indication, now being approved for treatment of relapsed and refractory multiple myeloma (R/R MM) in patients undergoing their third line of treatment (the indication was previously limited to fourth line treatment). The approval of the amended indication by European Commission follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP). The approval positions Abecma® as the first CAR-T cell therapy approved in the European Union for adult patients with R/R MM undergoing their third line of treatment.
On 20 March 2024, Alvotech announced its full year financial results for 2023, highlighting increased product revenue and Alvotech’s acceptance of an offer from a group of investors for the sale of approximately 10 million ordinary shares in an Alvotech subsidiary for an approximate gross value of US$166 million, the net proceeds to be used for working capital. (Alvotech subsequently announced on 22 March 2024 the issue of 13,000,000 new ordinary shares to that subsidiary).
The announcement also noted recent pipeline highlights including US approval of AVT02 (marketed as Simlandi®), biosimilar to Humira® (adalimumab), addressing an earlier CRL for the Reykjavik facility, approval of AVT04, biosimilar to Stelara® (ustekinumab) in Canada and Europe, and positive top-line results from studies on AVT05, biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, biosimilar to Eyelea® (aflibercept) and AVT03, biosimilar to Prolia® and Xgeva® (denosumab). On the associated webcast Alvotech responded to a question by noting it is preparing for potential manufacturing/product changes to Keytruda®, reference product for AVT33 (pembrolizumab).
On 20 March 2024, China Daily reported that Novo Nordisk has announced investing USD 560 million in its Chinese facility (in Tianjin which was first opened in 1994) as part of its expansion project to further increase manufacturing capability to support the localization of more innovative medicines. The project also encompasses the development of a state-of-the-art filling facility equipped with isolator technology. Novo Nordisk has already started development and the expansion is estimated to be completed in 2027.
On 20 March 2024, Lonza announced it has entered an agreement to acquire Genentech’s large-scale biologics manufacturing site in Vacaville, California (US) from Roche for US$1.2 Billion.
The facility has a total capacity of around 330,000 liters which is reported to be one of the largest biologics manufacturing sites in the world by volume.
Under the agreement, approximately 750 of Genentech’s employees at the facility will be offered employment by Lonza. Lonza plans to invest approximately US$556 million to upgrade the facility and enhance its capabilities for commercial contract manufacturing.
On 19 March 2024, Dr. Reddy’s announced the launch of its Versavo® (bevacizumab) in the UK. Versavo® is a biosimilar to Genentech’s Avastin®(bevacizumab) and is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer. Versavo® is Dr. Reddy’s first biosimilar product to be approved and launched in the UK and is supplied in 100mg and 400mg single use vials.
Versavo® was launched in India just under 5 years earlier, in August 2019. The first bevacizumab biosimilar was approved in the UK in January 2018 resulting in Dr Reddy’s launching its biosimilar more than 6 years after the first approved biosimilar.
On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada. The announcements did not disclose the permitted launch dates for FYB202 in those regions.
In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”.
On 18 March 2024, Bio-Thera Solutions announced that it is partnering with SteinCares to commercialise two unnamed biosimilars in LATAM. SteinCares will have exclusive right to distribute and market Bio-Thera’s two biosimilar pharmaceuticals in LATAM and Bio-Thera is responsible for and regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region. Bio-Thera is responsible for commercial supply out of its manufacturing facilities in Guangzhou, China.
On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first subcutaneous formulation of infliximab approved by the U.S. FDA in 2023. Zymfentra is approved for maintenance therapy in adults with active ulcerative colitis or Crohn’s disease following an induction treatment regimen with an intravenous infliximab product.
Celltrion emphasised that the sub-cutaneous administration method offers patients greater flexibility in managing their disease. According to Celltrion, ZYMFENTRA™ is patent protected until 2037 for the formulation and 2040 for the method of treatment.
On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales. Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab) in the US and entering an agreement to commercialise Samsung Bioepis’ SB17 (biosimilar to Janssen Biotech’s Stelara®) in the US, Canada, EEA, Switzerland, and UK.
In March 2024, Sandoz announced completion of its acquisition of Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.
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.
Chantal Savage
Special Counsel, Lawyer
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Faran Shahzad
Foreign Qualified Lawyer (NZ)
Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions.
With a background in physiology, Faran is passionate about life sciences industries. His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.