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Biosimilars Deals 2022

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

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.

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.

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.

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).

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.