31 May 2024 | EU | US | Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment
On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD).
This comes after the FDA accepted Dupixent® for priority review for the same indication in February 2024. The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.
30 May 2024 | Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar
On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June 2024.
The analysis compared the proportion of patients with paroxysmal nocturnal hemoglobinuria (PNH) who remained transfusion-free when treated with SB12 or Soliris®. Samsung Bioepis reports that the data “adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients”.
Epysqli® (SB12) was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.
Epysqli® is one of two eculizumab biosimilars approved in Europe, including Amgen’s Bekemv®, which was EMA approved in April 2023.
Alexion filed proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking provisional measures in relation to EP 3 167 888 (method of treating PNH). In January 2024, Alexion also commenced US BPCIA litigation against Samsung Bioepis alleging infringement of 6 US eculizumab patents.
30 May 2024 | KR | Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea
On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea’s Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept). Eydenzelt was approved for the same indications as Eylea® including wet macular degeneration and diabetic macular oedema.
Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.
In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept. These proceedings are ongoing.
30 May 2024 | US | Temporary Restraining Order Against Biocon Extended in US Aflibercept Patent Brawl
As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron. The purpose of the temporary order was to maintain the status quo until preliminary injunction motions were heard.
On 30 May 2024, the temporary restraining order was extended for a further 14 days to allow additional time for the adjudication of the preliminary injunction motions. Preliminary injunction motions are pending against each of Biocon, Celltrion, Formycon and Samsung Bioepis in respect of alleged infringement of US Patent No. 11,084,865 (ophthalmic formulations of a VEGF antagonist).
30 May 2024 | EU| CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).
The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU. However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021.
Avzivi® was FDA approved in December 2023.
29 May 2024 | US | FDA Priority Review of MSD’s sBLA for Keytruda® + Chemo for Malignant Pleural Mesothelioma
On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. The target action date for the FDA decision is 25 September 2024.
This comes weeks after Amgen announced initiation of a Phase 3 study to evaluate its pembrolizumab biosimilar for advanced or metastatic non-squamous non-small cell lung cancer.
29 May 2024 | MSD Acquires EyeBio for US$3B
On 29 May 2024, Merck (MSD) announced the acquisition of privately owned opthalmology focussed biotech EyeBio for US$3 billion, including an upfront payment of US$1.3 billion and $US1.7 billion in milestone payments. The acquisition has been unanimously approved by EyeBio’s board, and is expected to close in Q3/2024.
EyeBio’s lead candidate, Restoret™ (EYE103), is a tri-specific antibody for diabetic macular oedema (DME) and neovascular age-related macular degeneration and is expected to enter pivotal studies for DME in the second half of 2024.
In March 2024, MSD completed its acquisition of Harpoon Therapeutics for about US$650M with the aim of augmenting and diversifying its oncology pipeline.
28 May 2024 | US | Amgen Sues Celltrion Over Denosumab Biosimilar
On 28 May 2024, Amgen filed a complaint against Celltrion in the United States District Court for the District of New Jersey alleging infringement of 29 patents relating to denosumab. The allegations relate to Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).
In May 2023, Amgen sued Sandoz in the US over its denosumab biosimilars (Jubbonti® and Wyost®) asserting infringement of 21 denosumab patents. That dispute was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).
Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively. No other denosumab biosimilars have received US approval to date.
28 May 2024 | EU | UK | CH | Bio-Thera & STADA Enter Exclusive Commercialisation Agreement for Golimumab Biosimilar in EU, UK and Switzerland
On 28 May 2024, Bio-Thera and STADA announced they have entered an exclusive commercialisation agreement in relation to BAT2506, biosimilar to Janssen’s Simponi® (golimumab).
Under the agreement, Bio-Thera has responsibility for developing and manufacturing BAT2506, while STADA has exclusive rights to commercialise the product in the EU, UK, Switzerland and certain other unnamed countries. The agreement provides for an upfront payment to Bio-Thera of US$10M, plus milestone payments of up to US$147.5M, subject to fulfillment of certain conditions.
This comes after last month’s announcement by Alvotech of positive topline results from a confirmatory clinical study of its golimumab biosimilar, AVT05.
28 May 2024 | US | Approval Alert: FDA Approves Amgen’s Bkemv (eculizumab) as the First Interchangeable Biosimilar Ahead of March 2025 Launch
On 28 May 2024, Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab). Bkemv® is approved for the same indications as Soliris® (atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)) in the same dosage form and strength.
Bkemv® is set to be launched in the US in March 2025, under a settlement reached by Amgen and Alexion in May 2020.
Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® on 19 April 2023. On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab.
Alexion has also sued Samsung Bioepis in the UPC and the US alleging infringement of eculizumab patents. Samsung Bioepis’ SB12 (Epysqli®) was granted EU marketing approval in May 2023 and its aBLA was accepted by the FDA in July 2023
28 May 2024 | EU | Outlook Therapeutics Obtains First EU Approval For Ophthalmic Bevacizumab
On 28 May 2024, Outlook Therapeutics announced it received EU marketing authorisation for LYTENAVATM (ONS-5010, bevacizumab-gamma) 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 EU. The marketing authorisation grants LYTENAVATM 10 years of EU market exclusivity.
Outlook Therapeutics reports that it is aiming for the first commercial launch of the product in an EU Member State in Q1/2025.
Outlook Therapeutics is also seeking approval for ophthalmic bevacizumab in the UK, with its MAA submitted on 13 May 2024, and the US, having resubmitted a BLA to the FDA in August 2022.
27 May 2024 | KR | Approval Alert: Biogen’s Leqembi® (Lecanemab) Receives South Korean Approval for Treatment of Alzheimer’s Disease
On 27 May 2024, Eisai and Biogen announced that South Korea’s Ministry of Food and Drug Safety approved Leqembi® (lecanemab) for treating adults with mild cognitive impairment or mild Alzheimer’s disease.
Leqembi® is reportedly the first approved treatment to reduce disease progression and slow cognitive and functional decline in patients with Alzheimer’s disease. South Korea is the fourth country to approve Leqembi®, following the US in July 2023, Japan in September 2023, China in January 2024.
27 May 2024 | US | Fresenius’ Biosimilar Denosumab Application Accepted For FDA Review
On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab has been accepted for review by the US FDA as biosimilar to Amgen’s Prolia®. The biosimilar is to be indicated for osteoporosis, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. Following the April 2024 resolution of US BPCIA litigation, commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025.
On 28 May 2024, Amgen commenced BPCIA litigation against Celltrion in the United States District Court for the District of New Jersey, alleging infringement of 29 patents relating to denosumab. Celltrion applied to the FDA for marketing authorisation of its denosumab biosimilar, CT-P41, in December 2023.
27 May 2024 | CN | Boan Biotech’s Denosumab Biosimilar Approved in China
On 27 May 2024, Boan Biotech announced that its Boluojia® (BA11021, denosumab injection, 120mg) received marketing approval from China’s National Medical Products Administration (NMPA) as biosimilar to Amgen’s Xgeva®. Boluojia® is indicated for the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Boan Biotech reports that it intends to expand the approved indications for Boluojia® to include bone metastases from solid tumours and multiple myeloma.
Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia® (denosumab), was approved by China’s NMPA in November 2022 for postmenopausal women with osteoporosis at high risk of fractures.
In January 2024, Boan Biotech completed enrolment for its international, multi-centre, phase 3 studies of Boluojia® and Boyoubei®, which are being conducted simultaneously in Europe, the US and Japan.
27 May 2024 | Samsung Bioepis Switching Studies For Denosumab Confirm Safety & Efficacy
On 27 May 2024, Samsung Bioepis presented follow-up results from a Phase 3 study on SB16, biosimilar to Amgen’s Prolia® (denosumab). According to Samsung Bioepis, the study demonstrated that switching postmenopausal osteoporosis patients from Prolia® to SB16 produced comparable results up to 18 months in terms of efficacy, safety and immunogenicity. The results were presented at the 2024 European Calcified Tissue Society (ECTS) Congress in France.
12-month results from the Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2023.
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 MaiweijianTM).
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.