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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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LENZ has entered into an exclusive license & commercialization agreement with Arrotex to register & commercialize Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in Australia & New Zealand
As per the deal, Arrotex will obtain exclusive commercialization rights for Vizz for the treatment of presbyopia in Australia & New Zealand. In return,…
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CStone Pharmaceuticals has entered into an exclusive commercialization agreement with Arrotex for the commercialization of sugemalimab in Australia & New Zealand
As per the deal, Arrotex will be responsible for regulatory submissions & obtain exclusive commercialization rights for sugemalimab in Australia & New Zealand across all approved & future indications
In return, CStone will…
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IQVIA is expanding its collaboration with Kexing Biopharm to advance a global multi-product biosimilar development and commercialization program
As part of the collaboration, IQVIA will provide end-to-end development, regulatory, analytics, and commercialization support to accelerate Kexing’s global biosimilar expansion while maintaining high quality and scientific standards
The collaboration also integrates IQVIA’s AI-enabled clinical trial capabilities to streamline protocol design, site selection,…
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Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)
As per the deal, the partner will handle registration and commercialization in Malaysia
While Mabwell will oversee the development, manufacturing, and supply of the products
Ref: Mabwell | Image: Mabwell | Press Release
Related News: Mabwell Initiates P-III Trial for 9MW2821 in TNBC…
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Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan
As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market
Follitropin alfa is a recombinant FSH used for…
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BioLab balances innovation with real-world impact through a dual strategy that combines rapid commercialization of FDA-approved or near-market solutions like Imbed with continued investment in long-term innovations such as cureVision and terraplasma, ensuring both immediate clinical needs and future breakthroughs in wound care are effectively addressed.
BioLab’s growth is driven by sharp strategic discipline, focusing on chronic outpatient…
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Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies
As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…
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Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
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Bio-Thera Solutions expanded its partnership with Intas Pharmaceuticals for BAT2506, a proposed biosimilar of Simponi (golimumab), through an exclusive commercialization and licensing agreement for India
BAT2506 is a proposed golimumab biosimilar by Bio-Thera. Golimumab, a human IgG1 monoclonal antibody, targets TNF-α to reduce key inflammatory markers such as CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference drug is approved…

