Pearce IP BioBlast w/e 19 Jan 2024

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “readily addressable”.  The company believes it is in a position to receive FDA approval for AVT02 (adalimumab, biosimilar to AbbVie’s Humira®) and AVT04 (ustekinumab, biosimilar to Janssen’s Stelara®) by their respective goal dates of 24 February 2024 and 16 April 2024.

The European Commission granted marketing authorisation for AVT04 under the brand name Uzpruvo® – the first EU-approved biosimilar to Stelara® – on 10 January 2024.

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).  The approval was based on studies comparing Eylea® 8mg dosed at 12 or 16 week intervals compared to Eylea® 2mg dosed at 8 week intervals, following initial monthly doses.  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 is the licensee of exclusive marketing rights outside the US.

On 8 January 2024, Bayer received MA from the European Commission for Eylea® 8mg for the same indications as Japan.  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.

On 17 January 2024 Samsung Bioepis released its fourth US Biosimilar Market Report.  The quarterly report details recent prices of US-launched biosimilars, and market share and price trends.  The report covers the US-approved biosimilars on 14 INNs, of which 45 have been approved (including three in Q4 2023) and 38 launched.  Of note in relation to adalimumab, Samsung Bioepis points out that six months after the July 2023 launch of seven biosimilar products, biosimilar adoption in the US is at 2%.

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that  biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023, and the third report was published on 10 October 2023.

Business Korea reported that Celltrion launched its 80mg dose of Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in the US on 17 January 2024.  It is the same high-concentration (100mg/mL) formulation as the 40mg dosage form already available in the US.  Celltrion will launch a 20mg dose for paediatric patients in Q1 2024.

Last week Celltrion won several European bids to supply Yuflyma®.

The Hindu reported that Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for marketing authorisation for its trastuzumab (biosimilar to Genentech’s Herceptin®) from India’s Subject Experts Committee of the Central Drugs Standard Control Organization (CDSCO).

In relation to another molecule (ustekinumab), CuraTeq Biologics entered into an exclusive commercialisation agreement with BioFactura in July 2023.

Korea Biomed has reported that Samsung Bioepis will stop supplying the low concentration formulation of Adalloce®, biosimilar to AbbVie’s Humira® (adalimumab), in Korea.  Samsung Bioepis will continue to supply Adalloce® in two high-concentration formulations: Adalloce® prefilled syringe and pen (both 40mg/0.4mL).

Korea Biomed has reported that LG Chem plans to launch Xelenka®, its biosimilar to AbbVie’s Humira® (adalimumab), in Korea in the second half of 2024, despite obtaining approval from the Korean Ministry of Food and Drug Safety on 15 December 2023.  The report states that the company is “still considering sales strategies”.

Boan Biotech announced that it has completed enrolment for the international multi-centre comparative clinical phase III study of BA6101 and BA11021, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The studies are being condu­­cted simultaneously in Europe, the United States, and Japan.

Boan commenced the trials in May 2023.  BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world, and China’s NMPA has accepted Boan’s BLA for approval as an Xgeva^® biosimilar.

Biospectrum India reported that Indian-based Enzene Biosciences announced its plans to establish a continuous manufacturing site in Hopewell, New Jersey.  Enzene intends the manufacturing site to be operational in June 2024.  Enzene also announced its plans to “gradually expand” operations across the EU, US, Canada, Australia, and Japan.

Enzene launched its seventh Indian biosimilar (ranibizumab) on 24 November 2023.

Celltrion announced the next phase of its strategic transformation to focus on new drug development at the JP Morgan Healthcare Conference in San Francisco, California.  Celltrion discussed the company’s strategic priorities and progress, including its vision to move beyond biosimilars through the 2024 launch of Zymfentra® (the first and only FDA-approved subcutaneous infliximab product) and expansion into digital healthcare.  Celltrion will continue to develop a pipeline of biosimilars including antibody-drug conjugates, immune checkpoint inhibitors and multi-specific (bi/tri-specific) antibody drugs.  Celltrion aims to have a portfolio of 11 drugs by 2025 and a total of 22 drugs by 2030.