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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  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,…
4 days ago

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Gedeon Richter
NEWS

Gedeon Richter Receives the EC Approval for Tuyory (Biosimilar, RoActemra) 

Shots:  The EC has approved Tuyory, a biosimilar version of RoActemra (Tocilizumab) across the EEA countries   Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product   Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …
April 29, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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NEWS

Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…
April 17, 2026

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Bavarian Nordic
NEWS

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
April 17, 2026

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NEWS

Mabwell  Collaborates with a Strategic Business Partner to Commercialize of Mailishu and Maiweijian (Biosimilar, Prolia and Xgeva) in Malaysia   

Shots:  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…
April 16, 2026

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NEWS

Mochida Pharmaceutical Collaborates with Qilu Pharmaceutical to Develop & Commercialize of Follitropin Alfa (Biosimilar, Gonal‑f) Across Japan 

Shots:  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…
April 15, 2026

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NEWS

Mabwell  Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva) 

Shots:  The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors  Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may…
April 15, 2026

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