Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of Intas, on 23 June, and the EMA accepted the MAA submission on 14 July. Intas will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.
On 22 July 2021, Intas Pharma announced it had signed a commercialisation agreement with Meiji and Dong-A St, under which Intas receives exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.
Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions, Ltd in the District Court of Massachusetts in relation to Biogen’s BIIB800, (biosimilar tocilizumab). Genentech alleges that Biogen’s product, manufactured in China by Bio-Thera, will infringe 20 US patents, including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype). On 9 December 2022 Biogen announced that the FDA had accepted its aBLA for BIIB800.
Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation. Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation. Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA.
Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab), has been accepted for review by the FDA. This follows acceptance of its DRL_RI dossier for review by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Rituxan®/MabThera® is approved for rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
We reported on 20 January 2023 that Dr Reddy’s successfully completed clinical studies of DRL_RI for filing in the US, EU and other regions against Rituxan®. DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr Reddy’s directly in other jurisdictions.
Prime Therapeutics announced its 2023 recommendations for formularies that include AbbVie’s Humira® (adalimumab). The pharmacy benefit manager will recommend the coverage of the following adalimumab biosimilars to commercial clients:
- Amgen’s Amjevita® (low concentration) and Boehringer Ingelheim’s Cyltezo® (interchangeable low concentration); or
- Amgen’s Amjevita® (low concentration) and Samsung Bioepis/Organon’s Hadlima® (high and low concentration).
Prime is also recommending coverage of Cyltezo® for Medicare Part D formularies. On 10 July 2023, Cigna Health announced its preferred adalimumab biosimilars.
AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC), has been approved in China as a monotherapy to treat patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. The approval by China’s National Medical Products Administration is based on the results of the DESTINY-Breast04 Phase III trial.
Based on the same clinical trial, Enhertu® was approved in Japan for the above indication on 27 March 2023.
The Searle Company Limited announced that it has entered into a license agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and license the biosimilar drugs in Pakistan.
In March 2023, Mabwell announced that it had received Chinese marketing approval for Mailishu®, its denosumab biosimilar, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated. This is the first biologic treatment for this indication approved in India.
On 21 May 2023 Sanofi and Regeneron announced positive results from their phase III Dupixent® study in COPD patients with chronic obstructive pulmonary disease.
Samsung Bioepis has released its second US Biosimilar Market Report. The quarterly report has updated price details of all products with launched biosimilars including updated 2023 Q3 average sale price (ASP) trends and wholesale acquisition cost (WAC) trends. For adalimumab:
- Organon/Samsung Bioepis’ Hadlima® and Coherus’ Yusimry® have a low WAC: ~85% less than Humira®
- Celltrion’s Yuflyma®, Boehringer Ingelheim’s Cyltezo®, and Fresenius Kabi’s Idacio® have a high WAC, only -5~7% below Humira®
- Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Biocon Biologics’ Hulio® are offering two pricing options including both a low and a high WAC
Samsung Bioepis launched its first US Biosimilars Market Report on 18 April 2023, predicting that biosimilars will save US$181B in five years in the US.
Samsung Biologics announced in a regulatory filing with Korea Exchange that it has signed a ₩511B (US$390M) contract with Novartis to manufacture its products in Korea from 1 January 2023 through to the end of 2028. The exact products which will be produced at the plant have not been revealed.
The deal was announced on 7 June last year, when Samsung Biologics and Novartis signed a letter of intent for the deal. It was originally worth ₩100B (US$81M), however the companies have increased the investment by ₩411B.
On 4 July 2023, Samsung Biologics announced two manufacturing deals with Pfizer worth US$897M.
BeiGene announced in an SEC filing that it and Novartis have entered into a mutual termination and release agreement, terminating their agreement (announced on 19 December 2021) under which BeiGene granted Novartis an exclusive time-based option to receive an exclusive licence to develop, manufacture and commercialise ociperlimab. BeiGene will continue enrolment in the phase III AdvanTIG 302 trial of ociperlimab in combination with BeiGene’s PD-1 inhibitor tislelizumab for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC), whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations.
Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications tislelizumab.
Cigna Healthcare, a pharmacy manager, announced it will prefer adalimumab biosimilars Boehringer Ingelheim’s Cyltezo®, Sandoz’s unbranded adalimumab-adaz, and Sandoz’s Hyrimoz high-concentration formulation alongside the originator product, Abbvie’s Humira® on its national preferred, standard, performance, and legacy commercial formularies. Organon/Samsung Bioepis’ Hadlima®, in both high- and low-concentration formulations, will be preferred alongside Humira® on its value, advantage, and total savings formularies. The announcement will be effective from 1 September 2023.
In the first week of July 2023, seven biosimilars to AbbVie’s Humira® were made commercially available in the US.
Special Counsel, Lawyer
Kate is an experienced life sciences patent lawyer, providing IP leadership for product development and commercialisation across global markets in pharmaceuticals, biopharmaceuticals, medical technology and devices, digital health and diagnostics – from initial scoping through to post-launch. She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.
Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.