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Pearce IP BioBlast w/e 12 Jan 2024

by , | Jan 15, 2024

Korea Biomedical Review reported that Celltrion has won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) in Friuli-Venezia Giulia (FVG) and Sicily in Italy, as well as in the south eastern region of Netherlands. Celltrion will supply Yuflyma® for four and a half years in FVG, two years in Sicily, and for the next three years in the Netherlands.  Celltrion also won a bid to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) in Sicily for two years.

On 18 September 2023, Celltrion won bids to supply Yuflyma® in five other regions of Italy, amounting to 20% of the Italian adalimumab market.

Merck announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.

WuXi Biologics announced that it has signed a research service agreement with BioNTech under which Wuxi will receive a $20M upfront payment, and BioNTech is granted exclusive rights to develop therapeutic candidates from two undisclosed preclinical investigational monoclonal antibodies discovered by WuXi.  WuXi is eligible for additional payments including for R&D, regulatory and commercial milestones, and tiered royalties.

Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA).  The SAG is expected to meet before 31 March 2024.  The SAG is being convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation.

On 9 January 2024, the Chinese NMPA approved Leqembi® as a treatment for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.

Celltrion announced in a corporate filing that it applied to the FDA seeking interchangeable status for CT-P17 (Yuflyma®), biosimilar to AbbVie’s Humira® (adalimumab), on 9 January 2024.  On 2 October 2023 the FDA approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents.  The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics Drug Application (aBLA) for ABP938, Amgen’s biosimilar to Regeneron’s Eylea® (aflibercept).   Regeneron is seeking a preliminary and permanent injunction against Amgen, a finding of willful infringement, damages (ncluding enhanced damages for wilful infringement) and costs.

Regeneron filed its fourth aflibercept complaint in the US District Court for the Northern District of West Virginia against Formycon on 29 November 2023.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion(on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for Uzpruvo® (AVT04), the first EU-approved biosimilar to Janssen’s Stelara® (ustekinumab).  The marketing authorisation is valid in all European Economic Area countries, including the 27 European Union Member States as well as in Iceland, Liechtenstein, and Norway.  The announcements state the approval ‘paves the way’ for market entry as soon as possible after expiry of a European Supplementary Protection Certificate (SPC) for Stelara® in July 2024.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Uzpruvo® (AVT04) on 10 November 2023.

Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration (NMPA) in China for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  Eisai has begun preparation for launch in Q3 2024.

On 22 December 2023, it was reported that Eisai will apply to the US FDA to expand approval for Leqembi® for prevention of AD as soon as April 2026.  Leqembi® was approved in Japan on 25 September 2023, and received traditional approval in the US on 6 July 2023.

GSK and Aiolos Bio announced they have entered into an agreement for GSK to acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing respiratory and inflammatory conditions, for $1B upfront and up to $400M in milestone payments.  Aiolos’ AIO-001 is a monoclonal antibody (mAb) ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps.  AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals.

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).  Eylea® 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses, and in patients with stable visual outcomes intervals of up to five months may be considered.  Eylea® 8 mg is the only treatment in the EU approved for extended treatment intervals of up to five months in nAMD and DMO.

Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer has licensed the exclusive marketing rights outside the US.

On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.  The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the 8mg Eylea® for the treatment of nAMD and DMO in November 2023, however Eylea® is not approved for diabetic retinopathy in the EU.

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


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.

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