Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company. Coherus’ pipeline now has a number of new clinical-stage assets, including:
Toripalimab: an anti-PD-1 monoclonal antibody under BLA review for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
CHS-006: a TIGIT-targeted antibody currently in a phase I / II study in combination with toripalimab in patients with advanced solid tumours;
Casdozokitug (SRF388 or casdozo): a first-in-class IL-27-targeted antibody in phase II clinical trials in lung cancer and liver cancer; and
CHS-114 (SRF114): an ADCC-enhanced CCR8-targeted antibody in a phase I / II study as a monotherapy in patients with advanced solid tumors.
On 2 August 2023, Coherus announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, had quadrupled to US$26.7M since the last quarter.
The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar. Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.
Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.
Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023. The target date for the integration of Viatris was end Q3 2023.
On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’. The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.
The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.
Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018. The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.
The Korea Economic Daily reported that Celltrion, Inc. announced plans to enlarge its finished pharmaceuticals manufacturing facility at its Songdo campus in Incheon, and has allocated about ₩126B (US$95M) for the project. The expansion is scheduled to be completed by early 2026 and production to begin in 2027, with an annual production capacity of around 8 million liquid vials.
AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.
On 24 August 2023 AstraZeneca had Soliris® (eculizumab) approved in Japan for a new indication to treat paediatric patients with gMG.
The US Department of Health and Human Services (DHHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs selected for pricing negotiation as part of the Inflation Reduction Act 2022 (IRA). The negotiations with the relevant pharmaceutical companies will occur in 2023 and 2024, and any price negotiations will come into force in 2026.
The ten drugs selected were:
Bristol Myers Squibb / Pfizer’s Eliquis® (apixaban)
Eli Lilly / Boehringer Ingelheim’s Jardiance® (empagliflozin)
Johnson & Johnson’s Xarelto® (rivaroxaban)
Merck’s Januvia® (sitagliptin)
AstraZeneca’s Farxiga® (dapagliflozin)
Novartis’ Entresto® (sacubitril/valsartan)
Amgen’s Enbrel® (etanercept)
AbbVie / Johnson & Johnson’s Imbruvica® (ibrutinib)
Johnson & Johnson’s Stelara® (ustekinumab)
Novo Nordisk’s Novolog®/Fiasp® (insulin aspart)
Only two days after this announcement, on 1 September 2023, Novartis brought proceedings against the US Government, arguing that these pricing negotiations are unconstitutional. Other pharmaceutical companies have also sued the Government on this same legislation, including Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the industry group Pharmaceutical Research and Manufacturers of America.
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 the pharma/biopharma industries, resulting from 25 years' experience including as VP of IP in-house global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.