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Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

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argenx to Acquire Forte Biosciences for $2.2B

Shots: argenx has entered into a definitive agreement to acquire Forte Biosciences, strengthening argenx’s innovative immunology portfolio with FB102 As per the deal, argenx will acquire Forte Biosciences for $77/share in cash, representing a total equity value of ~$2.2B; closing is expected in Q3’26 FB102 is an anti-CD122 antibody showing clinical PoC in vitiligo & celiac disease, with…

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Key Biosimilars Events of June 2026 

Shots:  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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Redefining Asthma Care: Caterina Brindicci and James Teague on Breztri Aerosphere’s US Approval and the Future of Triple Therapy  

Shots  Breztri Aerosphere became the first and only fixed-dose triple-combination maintenance therapy approved in the US for asthma patients aged 12 years and older, expanding beyond COPD and reinforcing the role of single-inhaler triple therapy in advancing asthma care.  The approval strengthens AstraZeneca’s respiratory portfolio and long-term vision of transforming care beyond symptom control, with additional regulatory reviews…

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EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…

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AbbVie to Acquire Apogee Therapeutics for ~$10.9B

Shots: AbbVie entered into a definitive agreement to acquire Apogee Therapeutics for $135.11 per share in cash, at a total equity value of approximately $10.9B. The transaction is expected to close in Q3’26, subject to shareholder and regulatory approvals The acquisition strengthens AbbVie’s immunology portfolio by adding Apogee’s clinical-stage pipeline focused on inflammatory and immunological…

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Biogen to Acquire RayThera for ~$1B

Shots: Biogen has entered into a definitive agreement to acquire RayThera, expanding its immunology pipeline As per the deal, Biogen will acquire RayThera for ~$1B, incl. an upfront payment & clinical and regulatory milestone payments; closing is expected in Q3’26 Following closing, Biogen will lead development, manufacturing & global commercialization of RayThera’s assets, incl. the…

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SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara) 

Shots:  The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab)  Ustekinumab is a human interleukin-12 and -23 antagonist  Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis  Ref: Gov.br |   Image: SteinCares | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea   PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…

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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)  Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

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