Significant Developments in Biosimilars and Pharmaceuticals in 2024

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.