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INSIGHTS+

Key Biosimilars Events of September 2026  

Shots:   Sep 2026 saw key biosimilar developments across oncology, immunology, diabetes, and bone disorders, with companies including Cipla, Samsung Bioepis, Biocon, Henlius, Teva, and STADA advancing approvals, regulatory filings, and partnerships.   Major developments included FDA approvals for Teva’s Degevma (denosumab) and Meitheal’s high-concentration Yusimry (adalimumab), alongside CHMP’s positive opinion for Biocon Biologics’ Pebrilzo (pertuzumab) and…
3 days ago

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INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2026

Shots:  The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.  Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.  The…
September 15, 2026

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NEWS

Shilpa Biologicals and SPIMACO Bio Partner to Advance Access to PD-1 Inhibitor Biosimilars in MENA Region  

Shots:  Shilpa Biologicals has entered into an exclusive MENA licensing & commercialization agreement with SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars used in cancer immunotherapy  Shilpa Biologicals will lead exclusive development & manufacturing, with phased technology transfer to enable local biosimilar production in Saudi Arabia, while SPIMACO Bio will handle regulatory execution, market…
September 15, 2026

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NEWS

Biocon Secures 10-Year Pertuzumab Supply Agreement in Brazil  

Shots:  Biocon has entered into a partnership agreement with Bahiafarma & Bionovis for pertuzumab biosimilar in Brazil to advance production & commercialisation of the HER2+ breast cancer therapy under the country’s PDP program  The Biocon, Bahiafarma & Bionovis consortium received 100% allocation under 10-year PDP program for pertuzumab, providing exclusive access to the public healthcare…
September 8, 2026

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INSIGHTS+

Key Biosimilars Events of August 2026 

Shots:  In August, biosimilar approvals and launches gained strong momentum with Biocon’s Yesafili (Eylea) and Yesintek (Stelara), FDA approval of rituximab from Dr. Reddy’s and Fresenius Kabi, and Celltrion’s European launch of Omlyclo (Xolair).   Global licensing and commercialization partnerships continued to drive biosimilar expansion with collaborations spanning North America, Europe, ASEAN, and MENA markets.   The biosimilar pipeline continued to broaden across key therapeutic…
September 1, 2026

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NEWS

Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara) 

 Shots:  The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults  Yesintek was initially approved in November 2024  Ref: Biocon…
August 18, 2026

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NEWS

Mabwell Reports ASEAN Partnerships for Its Aflibercept Biosimilar (Biosimilar, Eylea) 

 Shots:  Mabwell has signed licensing and commercialization agreements with local partners in the Philippines, Vietnam, and Malaysia for its aflibercept biosimilar, a biosimilar version of Eylea  As per the deal, Mabwell and its partners jointly advance the product’s registration and commercialization in these markets  Aflibercept is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular…
August 11, 2026

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Samsung Bioepis
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Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU 

 Shots:  Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU  Opuviz (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications  Opuviz 40…
August 10, 2026

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INSIGHTS+

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…
August 4, 2026

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