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Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.
Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.
Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
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Cumberland has entered into an agreement to sell its portfolio of branded US products to an affiliate of Apotex for $100M in cash, which will create a platform to deliver specialty medicines
The move separates Cumberland’s commercial business from its R&D operations, allowing the company to focus on advancing its pipeline product candidates post-closing,…
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Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia
Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph
Denoza will be available in a prefilled syringe format
Ref: Apotex | Image: Apotex | Press Release…
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Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials
Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization
Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)
Ref: PRNewsWire | Image:…
Biosimilars are the key alternatives for expensive Biologics therapies and saving millions of dollars of patients spent in the treatment of multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency- safety- and efficacy to original biologic products. The companies are focusing…

