Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab). Under the agreement, Doer Bio will conduct the clinical study in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.
Merck and Moderna announce success in mRNA-4157/V940/Keytruda® trial
Merck and Moderna announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 (investigational personalized mRNA cancer vaccine), in combination with Keytruda® (pembrolizumab), demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus Keytruda alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Merck announced in October 2022 that it had exercised its option to jointly develop and commercialise mRNA-4157/V940.
Amgen to acquire Horizon Therapeutics
Amgen announced that it will acquire Horizon Therapeutics for $27.8 billion. Amgen reported that it expects the acquisition to strengthen its innovative therapeutic portfolio, adding a number of rare disease drugs to its portfolio, including Uplizna® (inebilizumab-cdon), Tepezza® (teprotumumab-trbw) and Krystexxa® (pegloticase)
Paras Biopharma creates new division for biosimilars “Paras Biologics”
Finland’s Paras Biopharmaceuticals announced the split of its biologics and biosimilars business units, with the establishment of a new division “Paras Biologics” focussed on biosimilars co-development and licensing opportunities. Paras Biopharma will continue to focus on new biologics activities.
Erasca and Pierre Fabre sign agreement for encorafenib and cetuximab
Erasca announced it has signed a clinical trial collaboration and supply agreement with Pierre Fabre for BRAFTOVI (encorafenib) within key international territories. Erasca reported that this agreement will support a clinical proof-of-concept trial evaluating ERAS-007 (oral ERK1/2 inhibitor) in combination with encorafenib and cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC).
Biocon Biologics completes acquisition of Viatris’ global biosimilars business
Biocon announced that its subsidiary Biocon Biologics completed its multi-billion dollar (part equity, part cash) acquisition of Viatris’ global biosimilars business on 29 November 2022. With the closing of the deal, Biocon Biologics 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. Biocon announced that Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.
Hikma and Celltrion sign ustekinumab agreement
Hikma Pharmaceuticals announced that it has signed an exclusive licence agreement with Celltrion for CT-P43 (biosimilar ustekinumab). Under the agreement, Hikma will receive exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.
Biocon announces financial results for Q2 2022
Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year. Biocon subsidiary Biocon Biologics’ acquisition of Viatris’ global biosimilars business is expected to close “soon”. Biocon announced that its subsidiary Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.
JSR and Similis Bio sign development and licence agreement for four biosimilars
JSR Life Sciences announced that its recently launched biosimilars business Similis Bio has entered into a development and licence agreement with Blau Farmaceutica for four biosimilar products targeting oncology, inflammation and blood disorders. Under the agreement, Similis Bio will provide full processes and associated IP for tech transfer to Blau; and Blau will use the licensed IP for GMP manufacturing and clinical development, and seek regulatory approval. JSR disclosed the global market value of these 4 products is USD 42B.
AbbVie acquires DJS Antibodies
AbbVie announced the acquisition of DJS Antibodies, a UK-based biotechnology company. DJS’ lead program is DJS-002, a lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently under investigation for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases.
Alvotech and JAMP expand exclusive partnership for CA
Alvotech announced that it has expanded its exclusive partnership with JAMP for Canada, adding AVT16 (immunology biosimilar) and AVT33 (oncology biosimilar) to their existing partnership. Under the agreement, Alvotech will be responsible for the development and commercial supply of the products, in exchange for milestone payments and future sales royalties. Alvotech and JAMP previously entered into a biosimilar commercialisation agreement for five biosimilar products in January 2020.
Jacobio Pharma and Merck enter into clinical trial collaboration for JAB21822 and Erbitux® (cetuximab)
Jacobio Pharma announced it has entered into a clinical trial collaboration agreement with Merck to study Jacobio’s JAB-21822 (KRAS G12C inhibitor) in combination with Erbitux® (cetuximab) for the treatment of KRAS G12C-mutated colorectal cancer.
Lupin and DKSH sign licensing and supply agreement for the Philippines
Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines. The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.
Genentech and Samsung Bioepis settle US BPCIA bevacizumab (Avastin®) dispute
Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims. Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 patents relating to bevacizumab (Avastin®). No further details about the settlement agreement have been disclosed.
Prestige Biopharma acquires more shares of Prestige Biologics
Prestige Biopharma announced that it will acquire more shares of Prestige Biologics, to secure a total of 24.88% of the CDMO company. Prestige Biopharma reported that the new structure will allow the group to establish a full value chain with a 154,000 L, global-scale production facility.
Merck proposed acquisition of Seagen
Merck & Co is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with negotiations presently having stalled due to a failure to agree on price. The acquisition could give Merck access to Seagen’s pipeline of antibody-drug conjugates (ADCs). Merck has previously announced strategic oncology collaborations with Seagen for two of its ADCs as well as Merck taking a USD1B equity stake in Seagen. Neither Merck nor Seagen have made any formal announcement about the purported acquisition.
Lupin and I’rom sign licence for denosumab in Japan
Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan. Under the agreement, I’rom and Lupin will together conduct clinical trials and obtain registration, and I’rom will then exclusively distribute and market the product in Japan.
Samsung Bioepis and Samil sign ranibizumab commercialisation agreement
Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab). Under the agreement, Samil is licenced to sell Amelivu® in Korea. Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022. Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.
Organon announces deal with Henlius for pertuzumab and denosumab
Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”. The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).
Civica selects Profil as clinical trial partner for affordable insulin initiative
Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative. In March 2020, Civica announced its plan to manufacture biosimilar insulins glargine, lispro and aspart. Civica plans to set a maximum recommended consumer price of no more than $30 per vial, or $55 for a box of five pen cartridges.
Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims
Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.
Formycon and Athos announce closing of acquisition
Formycon and Athos KG announced closing of the acquisition by Formycon of 50% of the rights to FYB201 (biosimilar ranibizumab), 100% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”. The total value of the deal is €650M.
Biogen completes the sale of its stake in the Samsung Bioepis joint venture
Axantia to commercialise ranibizumab biosimilar in the Middle East
Intas announced that it has signed an exclusive license and supply agreement with Axantia, a Middle Eastern pharmaceutical company, for the commercialisation of ranibizumab (biosimilar Lucentis®) in territories including Saudi Arabia, Jordan, Iraq and Lebanon.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
Naomi Pearce & Emily Bristow
Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate
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