Pearce IP BioBlast for w/e 12 July 2024

12 July 2024 | HK | IS | Approval Alert: Eisai’s Leqembi® (Lecanemab) Approved in Hong Kong and Israel for Alzheimer’s Disease
On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.

Leqembi® has previously been approved for the same indication in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.

11 July 2024 | EU | Fresenius’ Biosimilar Denosumab Applications Accepted for Review in Europe
On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®.

This comes after Fresenius’ BLA for denosumab was accepted for review by the US FDA on 27 May 2024, as biosimilar to Amgen’s Prolia®.  In June 2024, Fresenius presented results of a Phase 3 study demonstrating biosimilarity of its FKS518 (denosumab) with Amgen’s Prolia®.

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

11 July 2024 | US | Samsung Bioepis Releases Sixth Biosimilar Market Report; US Adalimumab Biosimilar Market Share Grows to 18%
On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report.  The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules.  Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s Selarsdi^TM (Stelara®, ustekinumab); Accord Biopharma’s Hercessi^TM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s Yesafili^TM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).

Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.

The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label.  The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.

10 July 2024 | US | Novo Nordisk Receives Complete Response Letter for Once-Weekly Insulin Icodec in US
On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus.  The CRL is said to include “requests related to the manufacturing process and the type 1 diabetes indication”.

Insulin icodec, under the brand name Awiqli®, was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024.  Awiqli® has been approved in Switzerland and Canada (March 2024) and Japan and Australia (June 2024) and was endorsed in China in June 2024 for Type 2 diabetes.  Novo Nordisk’s weekly insulin icodec injection is close to approval in India.

9 July 2024 | IN | Delhi High Court Issues Temporary Injunction Banning Sale of Zydus’ Pertuzumab Biosimilar
In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug Sigrima^TM, biosimilar to Roche’s Perjeta® (pertuzumab).  The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ Sigrima^TM and Dr Reddy’s co-marketed Womab® infringe Indian patent numbers IN 268632 and IN 464646.

The injunction is to remain in place until the next hearing date on 18 July 2024.

According to the Court order, Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtained permission to market the drug on 27 June 2024 and subsequently launched Sigrima™ on the Indian market.

On 28 June 2024, Zydus and Dr Reddy’s announced that they had entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India as Sigrima^TM (Zydus) and Womab® (Dr Reddy’s).

9 July 2024 | ID | Bio Farma Partners with Novo Nordisk to Package Insulin in Indonesia
Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia.  This is the first of Novo Nordisk’s packaging deals in Indonesia for insulin, which is manufactured in Denmark and the US.

This news follows Novo Nordisk’s US$4.1B investment to expand its US manufacturing capacity.

9 July 2024 | UK | Approval Alert: Celltrion’s Omlyclo® is First UK Approved Omalizumab Biosimilar
On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic idiopathic urticaria. Omlyclo® is the first omalizumab biosimilar approved in the UK.

Omlyclo® was also the first omalizumab biosimilar approved in Europe, in May 2024, and in South Korea, in June 2024.  Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.

Celltrion is currently defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

9 July 2024 | Study Finds Switching from Janssen’s Remicade® to Infliximab Biosimilars Safe and Effective
A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen’s Remicade® (infliximab) to an infliximab biosimilar during treatment.  The literature review also reported that clinical effectiveness outcomes were consistent between originator infliximab and biosimilar infliximab.

Infliximab biosimilars included in the review were those approved in the US, Canada, Europe, UK and Japan, including Celltrion’s Remsima®, Pfizer’s Inflectra®, Organon’s Renflexis®, Sandoz’s Zessly® and Samsung Bioepis’ Flixabi®.

The literature review follows findings earlier this year that patients with IBD who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.

8 July 2024 | UK | Outlook Therapeutics Secures First UK Marketing Authorisation for Ophthalmic Bevacizumab
On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first authorised ophthalmic formulation of bevacizumab in the UK.

Outlook Therapeutics’ submission to the MHRA was made under the International Recognition Procedure (IRP) introduced in January 2024.  This procedure allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.

The UK approval follows marketing authorisation granted to Lytenava™ in the EU in May 2024 for the same indication.

8 July 2024 | US | Just – Evotec Biologics and Sandoz Expand Biosimilars Partnership
On 8 July 2024, Just – Evotec, a subsidiary of Evotec SE, announced that it has expanded its partnership with Sandoz to develop and manufacture multiple biosimilars.  The deal was first entered into in May 2023 and is designed to utilise Just – Evotec’s AI driven drug substance development platform and continuous manufacturing technology to expand Sandoz’s pipeline.

In June 2024, Just – Evotec announced that it had been selected by the US Department of Defense to develop an accelerated monoclonal antibody development and manufacturing solution as part of the department’s Manufacturing Optimisation Program.

8 July 2024 | US | Approval Alert: FDA Approves Updates to Genentech’s Susvimo® (Ranibizumab) for nAMD
On 8 July 2024, Genentech announced that the FDA has approved the relaunch of Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, which is used for treating nAMD.

The FDA first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has now updated the Susvimo® implant and refill needle, and reports that testing confirms the performance standards are met.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.