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Significant Developments in Biosimilars and Pharmaceuticals in 2024

2024 has seen major advancements and approvals in the biosimilars and pharmaceutical sectors, including the launch of new treatments, regulatory approvals, and significant financial performances by leading companies.

Aflibercept

Amgen launched Aflibercept in the US and is preparing to launch Ustekinumab & Eculizumab following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen.

Bevacizumab

Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™, has been recommended by the National Institute for Health and Care for Wet AMD in the UK.

Denosumab

Amgen secured approval for 5 additional Denosumab brands in Australia, and Celltrion & Daewoong Pharmaceutical announced a joint sales agreement for a Denosumab biosimilar in Korea.

Dupilumab

Dupixent® was EU approved for children with Eosinophilic Esophagitis, marking a significant advancement in treatment options.

Golimumab

Alvotech/Advanz announced EMA acceptance for a biosimilar to J&J’s Simponi® (Golimumab), confirming a world first.

Liraglutide

A telehealth provider plans to offer generic Liraglutide in the US from 2025, expanding access to this treatment.

Trastuzumab deruxtecan

Alteogen partnered with Daiichi Sankyo on SC Enhertu® in a US$300M deal, highlighting the ongoing innovation in cancer treatment.

Ustekinumab

Celltrion launched its Ustekinumab biosimilar in the EU, and Alvotech urged the FDA to refuse to license Samsung Bioepis and Celltrion Ustekinumab biosimilars as interchangeable to Stelara®.

Company Announcements

Celltrion achieved record quarterly sales, Novo Nordisk reported strong financial performance, and Biocon's biosimilar business grew by 19% in Q3/2024.

Benralizumab

AstraZeneca’s Fasenra® was EU-approved for EGPA, offering a new treatment option for patients.

Elranatamab

Pfizer’s Elrexfio® was recommended by NICE for the NHS Cancer Drugs Fund in the UK.

Guselkumab

Positive Phase 3 results for J&J’s Tremfya® in Crohn’s Disease and Plaque Psoriasis were announced.

Infliximab

Celltrion announced positive results in a study comparing Infliximab SC monotherapy and immunosuppressant combination therapy.

Lebrikizumab

Eli Lilly announced positive results from the Phase 3b ADapt study for Ebglyss™.

Lecanemab

Eisai completed a fast-tracked BLA for Leqembi® maintenance dose autoinjector in the US.

Semaglutide

Novo Nordisk announced positive results from a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with liver health issues.

Pembrolizumab

MSD’s Keytruda® sales for Q3/24 reached US $7.4B, showcasing its continued success.

Sandoz

Sandoz reported strong biosimilars growth in its Q3/9M 2024 financial results, with third-quarter net sales up 12% in constant currencies.
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The European Commission (EC) has granted marketing authorization to aflibercept biosimilars developed by Sandoz (Afqlir) and Samsung Bioepis/Biogen (Opuviz) for treating retinal conditions like neovascular age-related macular degeneration (nAMD).
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Ustekinumab Biosimilars Approved, Data Support Biosimilar Safety, and Adalimumab Biosimilar Offers Cost Savings

The FDA approved ustekinumab-srlf (IMULDOSA) as a biosimilar to ustekinumab (STELARA) for treating chronic inflammatory conditions, based on comprehensive clinical data demonstrating similar pharmacokinetics, efficacy, safety, and tolerability.
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FDA Accepts Biologic License Application for Denosumab Biosimilar HLX14

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Regeneron Appeals Eylea Biosimilar Ruling; Prime Therapeutics Adds Humira Biosimilars; Denosumab Biosimilar Advances

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Korean Drugmakers Lead in Biosimilar Market and New Denosumab, Eculizumab Deals

Korean drugmakers dominate the biosimilar market with over 50% share in top-selling biosimilars, alongside new partnerships for denosumab and eculizumab biosimilars. Celltrion's denosumab biosimilar shows promise for affordable osteoporosis treatment, and Sandoz's biosimilar denosumab demonstrates equivalence to the originator.

Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data

Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira.
The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis.

Reference News

[1]
Biosimilars Deals 2021 Archives
pearceip.law · Nov 14, 2024

Amgen launches Aflibercept in the US, NICE recommends Outlook Therapeutics’ Bevacizumab for Wet AMD, Amgen secures Denos...

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