Xbrane Biopharma and AGC Biologics entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.
Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD $375 million with a further USD $50 million in contingent consideration payable upon the achievement of certain commercial milestones.
180 Life Sciences and Celltrion announced that they have entered into a Memorandum of Understanding for the supply of an anti-TNF biosimilar drug to be used for new indications with significant unmet medical needs.
BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.
Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.
Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, Saudi Arabia, UAE, Kuwait Qatar and Bahrain.
Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while Teva will gain commercialisation rights in Europe, Canada, Israel and New Zealand.
AbbVie announced it has received approval from Health Canada for Humira® (adalimumab) for the treatment of pediatric patients with ulcerative colitis.
Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.
Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.
PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
Reuters reported that Pfizer will stop producing biosimilar products in China and will sell an intended manufacturing site in Hangzhou to WuXi Biologics.
Merck announced it has filed a Form 10 registration statement with the US Securities and Exchange Commission in relation to its intended biosimilars and women’s health spinoff, Organon. Merck announced that Organon will function as a standalone, publicly traded company, with separation on track to be completed late in Q2 2021.
Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.
Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).
Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.
Lannett announces it has entered into an agreement with the HEC Group of companies for biosimilar insulin aspart. Under the agreement, Lannett will be responsible for funding most of the clinical development requirements, while HEC will continue to develop the product and manufacturing infrastructure.
Coherus Biosciences announces it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.
Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.
Prestige Biopharma announces it is set for an IPO in early February 2021. The IPO is expected to be worth US $348 million, with the majority of the funds to be reinvested in R&D.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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