Key Developments in Biosimilars and Pharmaceuticals in 2024
Wegovy® Launches in Australia
On 2 August 2024, Novo Nordisk announced the availability of Wegovy® (semaglutide) in Australia, specifically indicated for weight loss, following approval by Australia’s Therapeutic Goods Administration.
Certolizumab Biosimilar Rights Revert to Xbrane
1 August 2024 marked the day when Xbrane Biopharma regained full rights to Xcimzane™, a biosimilar to UCB’s Cimzia® (certolizumab pegol), for treating rheumatoid arthritis and psoriasis.
New Indication for Opdivo® in Australia
Bristol Myers Squibb’s Opdivo® (nivolumab) received a new indication for resectable non-small cell lung cancer (NSCLC) on Australia’s Pharmaceutical Benefits Scheme (PBS) as reported on 1 August 2024.
Teva’s Revenue Growth
Teva reported a 7% increase in Q2 2024 revenues, reaching US$4.2 billion, with significant contributions from its generics business and key biosimilar developments on 31 July 2024.
Canadian Approval for Ustekinumab Biosimilar
Celltrion announced on 31 July 2024 that Health Canada approved Steqeyma (CT-P43), a biosimilar to Janssen’s Stelara® (ustekinumab), for treating plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
Mexican Approval for Trastuzumab Biosimilar
Zydus Lifesciences received approval from COFEPRIS, the Mexican Regulatory Authority, to market Mamitra™, a biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer on 31 July 2024.
Significant PBAC Agenda in Australia
The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November 2024 meeting agenda, published on 31 July 2024, includes discussions on denosumab & ustekinumab biosimilars, a new Ozempic® strength, and aflibercept indication expansion.
Omalizumab Patent Dispute
A patent dispute over omalizumab between Novartis/Genentech and Celltrion was heard by the Unified Patent Court (UPC) on 31 July 2024.
Leqembi® Treatment Benefits for Alzheimer’s
Biogen and Eisai announced on 30 July 2024 that continuous treatment with Leqembi® (lecanemab) for three years reduced clinical decline in early Alzheimer’s Disease patients.
UK Court Revokes Stelara® Patent
Samsung Bioepis successfully invalidated the UK counterpart patent of Janssen Biotech Inc’s Stelara® (ustekinumab) on 30 July 2024.
European Approval for Bevacizumab Biosimilar
Bio-Thera Solutions and Sandoz’s Avzivi® (BAT1706), a biosimilar to Genentech’s Avastin® (bevacizumab), received EMA approval for treating various cancers on 30 July 2024.
New Indication for Vabysmo® in EU
Roche’s Vabysmo® (faricimab) was approved by the European Commission for macular oedema secondary to retinal vein occlusion (RVO) on 30 July 2024.
FDA Approves Darzalex Faspro® for Multiple Myeloma
Johnson & Johnson announced FDA approval for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with other drugs for newly diagnosed multiple myeloma patients on 30 July 2024.
Formycon’s Pembrolizumab Biosimilar Enters Phase III
Formycon began its Phase III trial for FYB206 (pembrolizumab), a biosimilar to MSD’s Keytruda®, on 30 July 2024.
Criminal Indictment for Counterfeit Cancer Drugs
A person from India was indicted by a US federal grand jury for trafficking counterfeit versions of MSD’s Keytruda®, Pfizer’s Adcetris®, and Bristol Myers Squibb’s Opdivo® on 29 July 2024.
Canadian Approval for Vabysmo® in RVO
Roche Canada announced Health Canada’s approval of Vabysmo® (faricimab) for macular edema secondary to retinal vein occlusion (RVO) on 29 July 2024.
NICE Recommends Against Trastuzumab Deruxtecan
NICE decided not to recommend trastuzumab deruxtecan (Enhertu®) for HER2-low breast cancer patients after chemotherapy in the NHS on 29 July 2024.
Amgen’s Xgeva® Approved in Korea
Amgen’s Xgeva® (denosumab) in a prefilled syringe formulation was approved by the Korean Ministry of Food and Drug Safety for patients with bone metastases from various cancers on 26 July 2024.
FDA Alert on Compounded Semaglutide
The US FDA issued an alert regarding dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®, on 26 July 2024.
Adverse IPR Decision for Aflibercept Patent
Regeneron faced an adverse Inter Partes Review (IPR) decision after disclaiming an aflibercept patent on 23 July 2024.