BioBlast w/e 25 Aug 23

Korea Biomedical Review reported that Celltrion has finalised an agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43, its biosimilar to Stelara®, in the US on 7 March 2025.  Celltrion submitted its aBLA to the FDA in June 2023, and is seeking to obtain marketing authorisation in 2024.

This follows J&J’s ustekinumab settlements with Fresenius Kabi and Formycon (AG) (with a US licensed entry date no later than 15 April 2025), Alvotech and Teva (with a US licensed entry date no later than 21 February 2025), Amgen (with a licensed entry date no later than 1 January 2024) and with Samsung (for an unknown licensed entry date).

Celltrion filed its MAA with the EMA for CT-P43 in May 2023.

Sandoz announced that the FDA approved its biosimilar Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri, for all indications covered by Tysabri®.  It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).  Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

This news comes just a week after Sandoz announced its spin-off from Novartis is planned for 4 October 2023.  On 21 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion Tyruko® to treat active relapsing remitting MS.

AstraZeneca and Merck announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the indication for Lynparza® (olaparib), to be used alongside abiraterone and prednisolone for adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer showcasing distant metastasis (mCRPC).  Lynparza® is the first PARP inhibitor approved in Japan demonstrating significant benefits in tandem with a new hormonal agent.

On the same day AstraZeneca also announced the MHLW expanded approval for Soliris® (eculizumab) to treat paediatric patients with gMG.

AstraZeneca announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for the extended use of Soliris® (eculizumab) to treat paediatric patients suffering from generalised myasthenia gravis (gMG). This approval specifically targets those who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control through high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris® is the exclusive targeted therapy cleared for treating gMG in Japanese children and adolescents.

On the same day AstraZeneca also announced the MHLW expanded approval for it and Merck’s Lynparza® (olaparib) with abiraterone to treat BRCAm mCRPC.

Korea Biomedical Review reported that Sam Chun Dang Pharm has licensed its aflibercept biosimilar to Apotex for Canada.  Under the agreement, Sam Chun Dang Pharmaceutical will receive an upfront payment of approximately 4 billion South Korean won.  Additionally, Sam Chun Dang Pharmaceutical expects to receive up to 50% of the gross profit if the PFS product is the first to be listed on drug coverage plans, or if it is listed within three months of the first biosimilar aflibercept PFS product.  If the product is listed within 4-6 months of other biosimilar aflibercept PFS products, Sam Chun Dang will receive 35% of the gross profit.

Korea Biomed reported that Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on the formularies of over 10 US insurers since its US launch on 17 April 2023.  One of these includes a top-five insurer in terms of patient enrolment.  While the exact insurers’ names remain undisclosed, the recent listings mean Vegzelma® is now accessible to roughly 30% of the US population. Celltrion aspires to amplify its coverage to surpass 60% of Americans by early 2023.

On 11 May 2023, Celltrion began supplying Vegzelma® in Italy and Belgium.

CVS Health has launched Cordavis, a subsidiary that will work with manufacturers to commercialise and/or co-produce biosimilars for the US market.  Cordavis has a contract with Sandoz to commercialize and bring to market Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®, in Q1 of 2024 under a Cordavis private label.  The list price of the Cordavis Hyrimoz® will be more than 80% lower than the current list price of Humira®.

On 1 July 2023, seven biosimilars to AbbVie’s Humira® (adalimumab), including Sandoz’s Hyrimoz® launched in the US.  Sandoz announced its global adalimumab settlement with AbbVie on 11 October 2018.

Reuters has reported that Johnson & Johnson’s Janssen will close part of its vaccine research and development programs.  The restructuring was announced in J&J’s Q2 2023 financial results (see page 56), where it notes the R&D program exits are primarily in infectious diseases and vaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development.

Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved in Japan for a new indication: to treat unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.

On 12 July 2023, Enhertu® was approved in the US for a new indication (unresectable or metastatic HER2-low breast cancer).

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that the EMA has partially approved its phase III IND for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus® to treat multiple sclerosis.  The trial will assess biosimilarity of CT-P53 and Ocrevus®.  The clinical trial plan has been divided into two parts Part 1 (assessment of clinical design and product characteristics) and Part 2 (assessment of national and institution-level documents).  The trial cannot commence until Part 2 has been approved by the EMA.

In the same week on 24 August 2023, Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on more than 10 US formularies since its US launch on 17 April 2023.

Celltrion submitted its phase III IND plan for CT-P53 to the US FDA on 15 May 2023.

BMS announced that the European Commission has expanded the indication for its Opdivo® (nivolumab) as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.  Opdivo® is now the only PD-1 inhibitor that is indicated to treat stages IIB, IIC, III, and IV resected melanoma.

On 21 July 2023, the CHMP issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma.

The Japan Times has reported that a Ministry of Health, Labour and Welfare (MHLW) committee has recommended approval of Eisai/Biogen’s Leqembi® (lecanemab).  The article notes that the committee’s endorsement will be followed by approval by the Health Minister in the coming days.

On 6 July 2023, Leqembi® was approved by the FDA in the US to treat Alzheimer’s disease.  The product label notes it should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Samsung Bioepis filed an IPR petition against Regeneron’s US10,464,992 relating to formulations of aflibercept.  Samsung Bioepis has sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

Samsung Bioepis has previously filed petitions against Regeneron’s method of treatment patent US11,253,572 in April 2023 and US10,888,601 in April 2023, with a third IPR previously filed against a third method of treatment patent US10,130,681 in January 2023.

Celltrion Group revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that Celltrion, Inc. and Celltrion Health Co., Ltd will merge as part of the initial phase of its merger plan.  Following this stage, the company will proceed with the second phase: a merger of Celltrion and Celltrion Pharm, Inc.  The company said the merger is expected to generate increased revenue through cost reduction and enhancement of cost competitiveness.  The company aims to reach 3.5 trillion KRW revenue and 1.6 trillion KRW EBITDA by 2024 and 12 trillion KRW revenue by 2030.

On 26 July 2023, Celltrion has applied to the Korean Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea.