Pearce IP BioBlast for fortnight ending 28 June 2024

28 June 2024 | Shanghai Henlius Biotech Completes Phase 1 Trials for Daratumumab Biosimilar

Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab).  The studies demonstrated that HLX15 has similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US, EU, and CN sourced Darzalex®.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).

28 June 2024 | US | Approval Alert: Formycon’s Aflibercept Biosimilar Approved in US

On 28 June 2024, Formcyon and Klinge Biopharma GmbH announced that FDA has approved FYB203, biosimilar to Regeneron’s Eylea® (aflibercept), for nAMD, Diabetic Macular Edema, Diabetic Retinopathy and Macular Edema following Retinal Vein Occlusion.  Klinge, which holds the global commercialisation rights for Formycon’s FYB203, will commercialise the biosimilar in the US as AHZANTIVE® (aflibercept-mrbb).

FYB203 is the third aflibercept biosimilar to be approved in the US, after Samsung Bioepis’ Opuviz and Biocon’s Yesafili® were both approved as biosimilars to Eylea® with interchangeability in May 2024.

The US launch dates for the biosimilars remain uncertain due to ongoing BPCIA patent litigation brought by Regeneron against Formycon, Samsung Bioepis and Biocon (amongst others) regarding aflibercept.  Preliminary injunctions were issued in relation to Formycon’s and Samsung Bioepis’ aflibercept biosimilars on 21 and 14 June 2024, respectively, while a permanent injunction was granted against Biocon on 11 June 2024.

28 June 2024 | Fresenius Adalimumab Switching Study Confirms Safety and Efficacy

On 28 June 2024, the results of a switching study on Fresenius Kabi’s® (MSB11022 adalimumab biosimilar) were published in Current Medical Research and Opinion, following presentation at the 2024 European Congress of Rheumatology (EULAR) earlier in June.  The study demonstrated that switching patients with rheumatoid arthritis from AbbVie’s Humira® (adalimumab) to Idacio® produced comparable results in terms of efficacy, safety and immunogenicity.

The first Humira® biosimilar (Amgen’s Amjevita®) was launched in the US on 31 January 2023, with multiple additional biosimilars entering the US market in July 2023.  In February 2024, Teva and Alvotech’s Simlandi® was FDA approved as the first interchangeable, high concentration, citrate free adalimumab biosimilar. Simlandi was launched in the US in May 2024.

28 June 2024 | IN | Zydus’ Pertuzumab Biosimilar to be Co-Marketed in India with Dr Reddy’s

On 28 June 2024, Zydus and Dr Reddy’s announced that they have entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India.  Dr Reddy’s receives semi-exclusive rights under the agreement, while Zydus will receive upfront and subsequent milestone payments.  Zydus will market its pertuzumab biosimilar to Roche’s Perjeta® under the trade name Sigrima™, with Dr Reddy’s supplying Womab®.

This comes after that New Delhi’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO), approved Zydus Life Sciences’ pertuzumab biosimilar for the additional indication of early breast cancer. CDSCO’s approval is conditional on Zydus conducting a Phase IV study of the drug for the new indication.

Earlier this month, results of a study sponsored by Qilu Pharmaceuticals were published demonstrating comparable efficacy and safety of Qilu’s QL1209 to Perjeta® (pertuzumab) in neoadjuvant treatment of HER2-positive, ER/PR-negative, early or locally advanced breast cancer.

27 June 2024 | KR | Samsung Bioepis’ Biosimilar Ustekinumab Korean Launch at 40% Discount

On 27 June 2024, Korea Biomedical Review reported that Samsung Bioepis intends to launch its ustekinumab biosimilar Epyztek™ in Korea in July 2024.  The product will be supplied at a 40% discount to J&J’s Stelara® (ustekinumab).

Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab) was approved by the South Korean Ministry of Food and Drug Safety for all Stelara® indications earlier this month.  No launch date for Steqeyma has been announced to date.

27 June 2024 | Coherus Abandons Adalimumab Biosimilar, Sells Rights to Hong Kong King-Friend for $40M

On 27 June 2024, Coherus BioSciences announced that it has agreed to divest its Yusimry™, biosimilar to AbbVie’s Humira (adalimumab), to Hong Kong King-Friend (HKF) for up-front all-cash consideration of USD $40M.  On the same day, Meitheal Pharmaceuticals, wholly owned subsidiary of HKF, announced it has received an exclusive US licence for the supply of Yusimry™ from HKF.

Meitheal expects to receive US approval for the high concentration formulation of Yusimry™ in 2025.

This divestment comes 12 months after a settlement between AbbVie and Coherus relating to AbbVie’s allegations of breach of contract relating to the Coherus settlement and licence agreement entered into in late 2019, under which Coherus received a royalty bearing non-exclusive licence to commercialise its biosimilar adalimumab Yusimry® from 1 July 2021.

Yusimry™ was launched in the US in July 2023, together with Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® pursuant to their respective settlement agreements with AbbVie.

27 June 2024 | Positive CHMP Opinion for Celltrion’s Ustekinumab Biosimilar

At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  The recommendation is for moderately to severely active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis.

This news follows approval of Steqeyma in South Korea earlier this month.  Celltrion is also seeking approval for Steqeyma in the US (FDA application submitted in June 2023) and Australia (TGA application submitted in April 2023).

Ustekinumab biosimilars currently approved in Europe are Alvotech and STADA’s Uzpruvo® (January 2024) and Samsung Bioepis’ Pyzchiva® (April 2024).  Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.

26 June 2024| CN | Approval Alert: Novo Nordisk’s Wegovy® Approved in China 

Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity.

The approval comes as the company plans a $4.1 billion expansion of its US manufacturing capacity.

On 17 April 2024, Biocon announced the signing of an exclusive licensing and supply agreement to provide generic Ozempic® (semaglutide) in Brazil. Earlier in the month, on April 10 2024, Boston-based Ginkgo Bioworks announced an expansion of its partnership with Novo Nordisk aimed at enhancing the manufacturing processes for Novo Nordisk’s medications, particularly those targeting chronic diseases like diabetes and obesity.  Meanwhile, on 2 April 2024, Hangzhou Jiuyan Gene Engineering announced that its Chinese application for Jiyoutai™, a biosimilar to Novo Nordisk’s Ozempic® (semaglutide) for type 2 diabetes, had been accepted.

25 June 2024 | US | Novo Nordisk Announces US$4.1B Investment to Expand US Manufacturing Capacity

On 25 June 2024, Novo Nordisk announced its plan to significantly boost its investment in manufacturing in 2024, allocating USD $6.8 billion towards production.  This is up from USD $3.9 billion the previous year.

The plan includes a USD $4.1 billion investment to build a second manufacturing facility in Clayton, North Carolina, expanding its capacity to produce injectable treatments for obesity and chronic diseases. The new facility will add 1.4 million square feet of production space and create 1,000 new jobs.

This news follows Ginkgo Bioworks’ announcement on 10 April 2024 of an expansion of its partnership with global healthcare leader, Novo Nordisk.

25 June 2024 | US | Samsung Biologics signs $156m Contract Manufacturing deal with US based Kiniksa

Business Korea reports that Samsung Biologics has entered a contract manufacturing agreement with US based Kiniksa Pharmaceuticals. The deal, valued at approximately USD $156m (211b won) covers the period 21 June 2024 to 31 December 2031.

This follows the announcement on 7 February 2024 that Samsung Biologics has partnered with Lego Chem Biosciences to develop and manufacture ADCs.

Earlier this year, Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products.

25 June 2024 | KR | Approval Alert: Celltrion’s Omlyclo is First Korean Approved Omalizumab Biosimilar

On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria.  This is the first omalizumab biosimilar approved in Korea.

Omlyclo® was also the first omalizumab biosimilar approved in Europe for allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.  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®.

Celltrion submitted an aBLA in the US for its omalizumab biosimilar (CT-P39) in March 2024 and in Canada in December 2023.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

24 June 2024 | EU | Approval Alert: Biogen’s Tocilizumab Biosimilar EU Approved

On 24 June 2024, Biogen announced its IV tocilizumab, TOFIDENCE™, biosimilar to Roche’s ROACTEMRA®, has been approved by EC.

This is the second tocilizumab biosimilar approved in the EU following the approval of Fresenius Kabi’s tocilizumab biosimilar, Tyenne® for the treatment of rheumatoid arthritis in September 2023.

This approval follows the positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for Tofidence in April 2024, and the FDA approval of Biogen’s Tofidence in September 2023.

24 June 2024 | US | Teva Announces US Launch of Authorised Generic Liraglutide

On 24 June 2024, Teva Pharmaceuticals announced the US launch of its authorised generic liraglutide injection (1.8 mg) for type 2 diabetes.  Originator Novo Nordisk supplies liraglutide as Victoza®, and Teva’s authorised generic Victoza is the first generic GLP-1 treatment available in the US.

This news follows Adalvo’s announcement on 13 June 2024 that its liraglutide pre-filled pen was approved in the EU, making it the first EU approved generic liraglutide.

21 June 2024 | US | New Indication Alert: FDA Approves Argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Chronic Inflammatory Demyelinating Polyneuropathy

On 21 June 2024, Argenx announced that the FDA approved a new indication of its VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART Hytrulo is approved for CIDP, administered as a subcutaneous injection once weekly lasting 30 to 90 seconds. It is notable as the only neonatal Fc receptor (FcRn) blocker approved for treating CIDP.

21 June 2024 | CN | Phase 3 Results for Qilu Pharmaceutical’s  Pertuzumab

Results of phase 3 pertuzumab studies comparing Qilu’s QL1209 with Roche’s Perjeta® with trastuzumab and docetaxel were published in the British Journal of Cancer on 21 June 2024.

The studies demonstrated that QL1209 is equivalent to Perjeta® in safety and efficacy for patients with HER2-positive, ER/PR-negative, early or locally advanced breast cancer.

QL1209 is reportedly the first pertuzumab biosimilar produced and submitted for approval in China.

21 June 2024 | US | US Court Grants Preliminary Injunctions Preventing Launch of Samsung Bioepis & Formycon Aflibercept Biosimilars

On 14 and 21 June, respectively, the United States District Court for the Northern District of West Virginia granted Regeneron’s motions for preliminary injunctions against Samsung Bioepis and Formcyon (unpublished to date), preventing them from launching their US biosimilars to Regeneron’s Eylea® (aflibercept).  The orders were made in the BPCIA litigation brought by Regeneron against each of Samsung Bioepis, Formycon, Biocon, Celltrion and Amgen. The order against Samsung Bioepis was published on 24 June 2024, while that against Formycon  remains under seal.

The preliminary injunction orders are based on the Court’s determination that Samsung Bioepis (Opuviz FDA-approved in May 2024) and Formycon (aBLA for FYB203 accepted by FDA in August 2023) infringed Regeneron’s US patent 11,084,864 (ophthalmic formulations of a VEGF antagonist).

Both Samsung Bioepis and Formycon lodged appeals from the preliminary injunction orders (on 14 June 2024 and 25 June 2024, respectively).  On 19 June 2024, Samsung Bioepis also filed an Emergency Motion to stay the preliminary injunction pending the appeal.

This comes after the Court granted Regeneron’s permanent injunction motion on 11 June 2024 (order published on 21 June 2024), preventing Biocon from launching its Yesafili (FDA approved in May 2024) in the US without a licence.   Biocon filed a Notice of Appeal on 21 June 2024.  Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023) and Amgen (aBLA for ABP 938 accepted by FDA in October 2023).

18 June 2024 | US | New Indication Alert: FDA Approves AbbVie’s Skyrizi® (Risankizumab) for Ulcerative Colitis

On 18 June 2024, AbbVie announced that the FDA approved its Skyrizi® (Risankizumab) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease.

AbbVie’s Skyrizi® (risankizumab) was approved in November 2023 by the Korean Ministry of Food and Drug Safety (MFDS) to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies.

18 June 2024 | EU | Alvotech & Advanz Pharma Partner on EU Aflibercept Biosimilars

On 18 June 2024, Alvotech announced that it has entered into an agreement with Advanz Pharma in relation to the commercialisation in Europe of Alvotech’s AVTO6 and AVT29, biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively.  Advanz Pharma’s commercialisation rights are exclusive throughout Europe, except in Germany and France, where they are semi-exclusive.

Under the agreement, Advanz Pharma is required to make an upfront payment to Alvotech, with further payments due on certain development and commercialisation milestones.

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, biosimilar to Novartis’ Xolair (omalizumab).  That agreement covered Europe, UK, Switzerland, Canada, Australia and New Zealand.

17 June 2024 | US | US Eculizumab Litigation Update: Court Refuses Alexion’s Motion For Emergency Injunction Against Samsung Bioepis

As previously reported, on 6 May 2024, the United States District Court for the District of Delaware refused to grant Alexion preliminary injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating paroxysmal nocturnal hemoglobinuria (PNH) (US 10590189) and atypical haemolytic uremic syndrome (aHUS) (US 9447176) with eculizumab.

On 14 May 2024, Alexion filed a Notice of Appeal from the Court’s decision denying the preliminary injunction and, on 17 May 2024, Alexion sought an emergency injunction pending the appeal.  On 17 June 2024, the Court refused Alexion’s motion for an emergency injunction, finding that there was a substantial question of validity in relation to the patents.

The injunction applications are part of the BPCIA litigation commenced by Alexion on 3 January 2024 alleging infringement of 6 patents relating to Samsung Bioepis’ aBLA for SB12, its biosimilar to Alexion’s Soliris® (eculizumab).  The litigation is ongoing.

SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024.

17 June 2024 | US | FDA Approves MSD’s Keytruda® Combo for Third Endometrial Carcinoma Indication

On 17 June 2024, Merck (known as MSD outside the US and Canada) announced that the US FDA has approved its anti-PD-1 therapy, Keytruda® (pembrolizumab) in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial carcinoma.

This is the first FDA-approved anti-PD-1 therapy for this indication and the third FDA-approved indication for Keytruda® in endometrial carcinoma.  Keytruda received FDA-approval in March 2022 as a single agent for advanced endometrial carcinoma that is MSI-H or dMMR, and in combination with lenvatinib for such cancer that is not MSI-H or dMMR.