Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean Ministry of Food and Drug Safety to treat rheumatoid arthritis, psoriatic arthritis, uveitis in adults, Crohn’s disease, and juvenile idiopathic arthritis in children. LG Chem obtained approval for its adalimumab biosimilar in Japan back in March 2021.
Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.
This approval comes considerably earlier than expected. Merck announced only in November 2023 that the FDA had accepted (for priority review) its new supplemental Biologics License Application (sBLA) seeking this approval. At that time the FDA had set a target action date of 9 May 2024.
Korea Biomedical Review reported that MSD Korea’s Tukysa® (tucatinib) was approved by Korea’s Ministry of Food and Drug Safety to treat HER2 (human epidermal growth factor receptor)-positive locally advanced or metastatic breast cancer that has recurred after at least two anti-HER2 treatments, in combination with the antibody therapy trastuzumab and the cytotoxic anticancer agent capecitabine. Tukysa is approved in over 38 countries.
Harbour BioMed’s wholly-owned subsidiary Nona Biosciences announced that it has entered into an exclusive license agreement with Pfizer for the global clinical development and commercialisation of HBM9033, Nona’s MSLN-targeted antibody-drug conjugate (ADC). MSLN is a tumor-associated antigen upregulated in various solid tumors. Nona will receive up to US$53M in upfront and near-term payments, with potential for payments up to US$1.05B contingent on achievement of development and commercial milestones.
In July 2023, Pfizer reached another large value deal with Samsung Biologics worth US$897M for Samsung’s manufacture of biosimilars.
Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that its phase III clinical trial of CT-P47, biosimilar to Genentech’s Actemra®/Roactemra® (tocilizumab), demonstrated equivalence with the originator product in patients with rheumatoid arthritis. Celltrion confirmed it intends to apply for approval for all indications that Actemra®/Roactemra® is approved for. On 31 May 2023 Celltrion released its phase I data for CT-P47.
Amgen announced that the FDA has accepted for priority review its Biologics License Application (BLA) for tarlatamab to treat patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The FDA assigned a PDUFA goal date of 12 June 2024.
Eisai and Biogen announced that Leqembi® intravenous infusion (lecanemab) will be launched in Japan on 20 December 2023, after it was scheduled on the Japan National Health Insurance (NHI) Drug Price List. Leqembi® intravenous infusion was approved in Japan on 25 September 2023 for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease.
Sandoz subsidiary Lek announced it has commenced construction of its US$400M biopharmaceutical production centre in Lendava, Slovenia. The facility aims to be Europe’s most efficient producer of active pharmaceutical ingredients for biologics, and will have approximately 40,000 m2 surface area. Full operation is planned for the end of 2026.
Sandoz signed an MOU to build the facility on 9 March 2023.
Celltrion USA announced that large Medical Benefits Manager Ventegra® will add Vegzelma®, Celltrion’s biosimilar to Genentech’s Avastin® (bevacizumab) on its commercial formulary as a preferred brand. Vegzelma® (bevacizumab-adcd) was approved by the FDA to treat six types of cancer in September 2022.
On 5 October 2023, Celltrion USA announced that Ventegra® will add Yuflyma®, Celltrion’s biosimilar to AbbVie’s Humira® (adalimumab) as a preferred drug to its formulary.
Lotus Pharmaceutical announced that it has entered into a partnership with Intas Pharmaceuticals for the commercialisation of Intas’s Prolia® (denosumab) biosimilar in South Korea, Taiwan and certain markets in South East Asia. According to the announcement, Intas will be responsible for development, manufacture and supply of the biosimilar, and Lotus will be responsible for the regulatory process and obtain commercialisation rights in those territories.
SystImmune and Bristol Myers Squibb announced that they have entered into an exclusive global license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate. Under the agreement the companies will jointly develop and commercialise BL-B01D1 in the US. SystImmune through its affiliates will be responsible for development, manufacturing and commercialisation in China and will be responsible for manufacturing certain drug supplies for use outside of China. BMS will be responsible for development and commercialisation of BL-B01D1 in the rest of the world.
BL-B01D1 is currently being evaluated in a global phase I study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC).
CEO, Executive Lawyer, Patent & Trade Mark Attorney
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.
Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.