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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,…
May 5, 2026

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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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NEWS

Mochida Pharmaceutical and AYUMI Pharmaceutical Receives Manufacturing & Marketing Approval for Tocilizumab BS MA (Biosimilar, Actemra) in Japan  

Shots:  The company has received manufacturing and marketing approval in Japan for tocilizumab BS MA, a biosimilar version of Actemra (tocilizumab)   Tocilizumab BS MA, a biosimilar jointly developed by Mochida Pharmaceutical and Gedeon Richter. Under their agreement with AYUMI Pharmaceutical, Mochida will supply the product, while AYUMI will handle its sales in Japan   Mochida Pharmaceutical…
March 23, 2026

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Gedeon Richter
NEWS

Gedeon Richter Receives the CHMP Positive Opinion for Tuyory (Biosimilar, RoActemra) 

Shots:  The CHMP has recommended marketing authorization for Gedeon Richter’s Tuyory, a biosimilar version of RoActemra (Tocilizumab)  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 …
February 27, 2026

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TOP 20

Top 20 Generic Pharma Companies of 2025 

Shots:  Generic medicines play a pivotal role in offering cost-effective alternatives to high-priced pharmaceuticals. They often serve as a critical lifeline in developing and underdeveloped nations, helping to address both chronic and infectious diseases.  In 2024, the global generics market was valued at $445.62B, with projections to reach approximately $468.08B in 2025 and ~$728.64B by…
October 8, 2025

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Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)
NEWS

Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)

Shots: Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar version of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditions As per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…
August 25, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada 

Shots:  Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada  Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…
May 21, 2025

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Biogen & Organon
NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…
April 2, 2025

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