Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year. Biocon’s acquisition of Viatris’ global biosimilars business is expected to close “soon”. Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.
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 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 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 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 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 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 & 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 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.
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 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 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 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 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.
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.
Formycon and Athos KG announced that they have agreed to enter into a long-term strategic partnership regarding biosimilars. As part of this agreement, Formycon will acquire 100% of the rights in FYB202 (biosimilar ustekinumab candidate) and a 50% stake in FYB201 (biosimilar ranibizumab candidate) in exchange for EUR 650 million.
Aurobindo announced that it will acquire certain business assets from Veritaz (the supplier of branded generic formulations and other health care products) for Rs 171 crore on a debt free basis. The acquisition will support Aurobindo’s plans to manufacture biosimilars and other products in India.
The Juvenile Diabetes Research Foundation and Civica announce partnership for affordable biosimilar insulins
The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®). Biosimilar insulins are to be developed for the US market so that low-cost insulin is supplied irrespective of insurance status from 2024. JDRF is underwriting the initial development costs of the project, and Civica will manufacture and distribute biosimilar insulin for less than USD$30/vial, or $55/box of five pen cartridges.
AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments. This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portfolio, including lead molecule SDI-118, a small molecule which is currently in Ph Ib studies.
Biocon announced that it will acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash to create a vertically integrated biosimilars leader. The transaction is expected to close in the second half of 2022, subject to conditions including certain regulatory approvals. The subject business revenues are expected to be USD1billion in 2023 alone.
Alvotech and Fuji Pharma announced that they have expanded their strategic partnership for Japan to include an undisclosed biosimilar currently in early phase development. This brings the total number of products covered by the partnership to six. Fuji will receive exclusive commercial rights to this biosimilar in Japan in exchange for upfront and milestone payments tied to development progression. Alvotech will also receive a share of the in-market sales.
Biogen and Xbrane Biopharma announced that they have entered into a commercialisation and license agreement to develop, manufacture and commercialise Xcimzane™ (proposed biosimilar certolizumab pegol).
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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