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 NMPA acceptance of United Laboratories’ IDegLira biosimilar.   Partnerships also remained prominent, with Cipla-Qilu and STADA-Sino Biopharmaceutical advancing pembrolizumab biosimilars, while mAbxience-Sandoz partnered on an emicizumab biosimilar and Biocon secured a 10-year pertuzumab supply agreement in Brazil.  Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US        Company: Cipla & Qilu Pharmaceutical       Product: QL2107       Active Ingredient:  Pembrolizumab       Reference Product: Keytruda       Reference Product Company: Merck        Disease: All Approved Indications        Date: Sep 03, 2026   Shots:  Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US  As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the defined territory using its established commercial presence  Keytruda is a humanized anti-PD-1 monoclonal antibody that blocks PD-1 interactions with PD-L1/PD-L2, activating T cells to help the immune system detect and fight tumor cells   Editor’s Take: Beyond the Headlines  Cipla’s entry into the US pembrolizumab biosimilar market could intensify competition around Keytruda, particularly as patent and exclusivity barriers evolve. Qilu’s development and supply capabilities combined with Cipla’s US commercial infrastructure may enable faster market penetration, increasing pricing pressure and expanding access to PD-1 therapy.  Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar        Company: Samsung Bioepis       Product: Ustekinumab BS Intravenous Infusion 130mg 「NIPRO」       Active Ingredient:  Ustekinumab       Reference Product: Stelara       Reference Product Company: Johnson & Johnson       Disease: Moderate to severe active Crohn’s disease       Date: Sep 03, 2026   Shots:  The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for the induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective  Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026   The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focussed on developing & commercializing multiple biosimilars in Japan, incl. ustekinumab  Editor’s Take: Beyond the Headlines  Samsung Bioepis’ IV ustekinumab approval strengthens its position in Japan’s immunology biosimilar market and expands competition with Stelara. Combined IV and SC formulations could support broader patient access and switching opportunities, while NIPRO’s commercialization capabilities may accelerate uptake and increase pricing pressure on the reference product.  Biocon Secures 10-Year Pertuzumab Supply Agreement in Brazil    Company: Biocon      Product: Pertuzumab     Active Ingredient:  Pertuzumab      Reference Product: Perjeta       Reference Product Company: Genentech, a member of the Roche Group      Disease: HER2+ Breast Cancer Therapy      Date: Sep 08, 2026   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 market, and supporting long-term adoption in the public oncology network   Biocon will receive milestone payments and a share of revenues from the Brazil PDP opportunity over 10 years, with the product undergoing phased localization in Brazil over the mid to long term  Editor’s Take: Beyond the Headlines  Biocon’s 10-year PDP agreement gives it a strong, protected foothold in Brazil’s public oncology market for pertuzumab, strengthening its biosimilar position against Roche’s Perjeta. The 100% allocation and planned local manufacturing could support sustained adoption, supply security, and long-term revenue visibility  Henlius Reports NMPA NDA Acceptance of 120mg (1.7mL) per Vial Strength of HLX14 (Biosimilar, Denosumab)   Company: Henlius    Product: HLX14   Active Ingredient: Denosumab    Reference Product: Prolia/Xgeva     Reference Product Company: Amgen    Disease:  Bone Metastases from Solid Tumors and Multiple Myeloma & Giant Cell Tumor of Bone       Date: Sep 11, 2026   Shots:  The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation    NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms of quality, safety, & efficacy   HLX14 products Bildyos and Bilprevda received marketing approvals in the US, EU and UK in H2’25, followed by approval in Canada in Mar 2026 under the trade names Bildyos and Tuzemty    Editor’s Take: Beyond the Headlines  NMPA acceptance of HLX14’s NDA expands Henlius’ denosumab biosimilar development into China, complementing its approvals across the US, EU, UK and Canada. Entry into China could significantly broaden its commercial reach while intensifying competition with Prolia and Xgeva, potentially supporting greater access and pricing pressure.  Shilpa Biologicals and SPIMACO Bio Partner to Advance Access to PD-1 Inhibitor Biosimilars in MENA Region   Company: Shilpa Biologicals & SPIMACO Bio   Product: PD-1 Inhibitors   Disease:  Cancer   Date: Sep 15, 2026   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 access & commercialization across the MENA region  The partnership aims to expand access to affordable immunotherapy, strengthen Saudi Arabia’s biomanufacturing capabilities, support Vision 2030 goals, & create long-term value for Shilpa Biologicals   Editor’s Take: Beyond the Headlines  The Shilpa–SPIMACO partnership could strengthen their position in MENA’s growing oncology biosimilar market by combining manufacturing expertise with regional market access. Localized production in Saudi Arabia may improve supply security and cost competitiveness, while intensifying competition for originator PD-1 therapies and existing biosimilar players.  mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally     Company: mAbxience and Sandoz       Product: Emicizumab Biosimilar      Active Ingredient: Emicizumab      Reference Product: Hemlibra       Reference Product Company: Roche      Disease:  Hemophilia A      Date: Sep 18, 2026   Shots:  mAbxience & Sandoz have entered into a licensing, development, manufacturing & commercialization agreement for an emicizumab biosimilar candidate  As pe the deal, mAbxience will develop & manufacture the biosimilar at its GMP-approved facilities in Spain & Argentina, while Sandoz will hold exclusive global commercialization rights (excl. Argentina, Uruguay & Paraguay); financial terms remain confidential  Emicizumab is a humanised monoclonal antibody, sold under the brand name Hemlibra for the treatment of hemophilia A   Editor’s Take: Beyond the Headlines  The mAbxience–Sandoz deal positions the companies to challenge Hemlibra in the hemophilia A market with a potential biosimilar, combining mAbxience’s manufacturing capabilities with Sandoz’s global commercial reach. A lower-cost alternative could expand access while increasing competitive and pricing pressure on Roche’s franchise.  Biocon Biologics Reports the CHMP Positive Opinion on Pebrilzo (Biosimilar, Perjeta)     Company: Biocon Biologics       Product: Pebrilzo     Active Ingredient: Pertuzumab      Reference Product: Perjeta      Reference Product Company: Genentech, a member of the Roche Group      Disease:  HER2+ Breast Cancer      Date: Sep 21, 2026   Shots:  The CHMP has recommended Pebrilzo, a biosimilar version of Perjeta (pertuzumab), as the 420 mg concentrate solution for infusion for the treatment of HER2+ breast cancer across multiple disease stages     The EC will conduct the final review and issue its decision; if positive, the SmPC will be available in all EU official languages, with the EPAR published on the EMA website in the following wks.  Pebrilzo is a monoclonal antibody that binds with high affinity and specificity to HER2, inhibiting the proliferation of tumor cells that overexpress HER2   Editor’s Take: Beyond the Headlines  Biocon Biologics’ positive CHMP opinion for Pebrilzo brings another pertuzumab biosimilar closer to EU commercialization, intensifying competition with Roche’s Perjeta. Combined with Biocon’s Brazil PDP agreement, the milestone strengthens its global oncology biosimilar footprint and could improve access while increasing pricing pressure in HER2+ breast cancer.  The NMPA Accepts The United Laboratories’ Marketing Application for IDegLira Biosimilar   Company: The United Laboratories   Product: IDegLira Biosimilar   Active Ingredient: Insulin degludec + liraglutide    Reference Product: Xultophy    Reference Product Company: Novo Nordisk    Disease:  Diabetes    Date: Sep 24, 2026   Shots:  China’s NMPA has accepted marketing registration application for insulin degludec & liraglutide injection (IDegLira), developed by TUL’s wholly owned subsidiary Zhuhai United Bio-Pharmaceutical    IDegLira is a once-daily fixed-dose combination of basal insulin degludec and the GLP-1 analogue liraglutide for type 2 diabetes, designed to provide complementary glucose-lowering effects while simplifying treatment   Through complementary and synergistic mechanisms, the combination overcomes monotx. limitations, providing stable 24hr. glycemic control, improving glycemic target attainment, and addressing weight management & hypoglycemia risk  Editor’s Take: Beyond the Headlines  NMPA acceptance of TUL’s IDegLira application strengthens its position in China’s growing diabetes combination-therapy market. As a once-daily fixed-dose insulin/GLP-1 option, the product could compete on convenience and comprehensive glycemic control, potentially challenging established combination therapies and supporting broader treatment adoption.  Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva)        Company: Teva       Product: Degevma       Active Ingredient: Denosumab-adet       Reference Product: Xgeva       Reference Product Company: Amgen       Disease:  All Indications       Date: Sep 28, 2026   Shots:  The US FDA has approved Degevma, a biosimilar version of Xgeva (denosumab) following FDA approval of Ponlimsi (biosimilar, Prolia) in Mar 2026, with launch of both biosimilars anticipated in coming mos.  Approval was backed by extensive data, incl. analytical & clinical data showing similar efficacy, safety & immunogenicity profile as the reference product  Degevma prevents bone complications in adults with advanced cancer that has spread to the bone, treats giant cell tumors of bone in adults & skeletally mature adolescents, & manages hypercalcemia of malignancy     Editor’s Take: Beyond the Headlines  Teva’s Degevma approval adds another denosumab biosimilar competitor to the US market, intensifying pressure on Amgen’s Xgeva. With Ponlimsi also approved, Teva can leverage a broader denosumab portfolio across oncology and osteoporosis, potentially driving greater payer competition, lower treatment costs, and expanded access.  Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)      Company: Meitheal Pharmaceuticals       Product: Yusimry       Active Ingredient: Adalimumab-aqvh       Reference Product: Humira       Reference Product Company: AbbVie        Disease:  All Indications       Date: Sep 28, 2026   Shots  The US FDA has approved a citrate-free, high-concentration formulation for Yusimry as an interchangeable biosimilar to Humira (adalimumab)  Yusimry, a TNF blocker, is available in low and highconcentration formulations via autoinjector, with the low-concentration formulation also available as a PFS  Emerge Bioscience holds the approved BLA for Yusimry, while Meitheal serves as its US Regulatory Agent & holds exclusive US commercialization rights under its license agreement with Emerge   Editor’s Take: Beyond the Headlines  FDA approval of Yusimry’s high-concentration, citrate-free formulation strengthens Meitheal’s position in the crowded US adalimumab market. Interchangeability plus autoinjector convenience can improve substitution potential and payer uptake, increasing competitive pressure on Humira and other biosimilars while expanding patient choice across formulations.  STADA and Sino Biopharmaceutical Partner to Advance Biosimilar Access      Company: STADA and Sino Biopharmaceutical       Product: TQB3570       Active Ingredient: Pembrolizumab        Reference Product: Keytruda       Reference Product Company: Merck       Date: Sep 28, 2026   Shots:  STADA and Sino Biopharmaceutical, through its subsidiary CTTQ, have entered into a strategic biosimilar partnership designed to broaden patient access to biological medicines in key markets  As per the deal, CTTQ will develop, manufacture & supply the biosimilar candidates, while STADA will hold marketing authorizations and exclusive sales & marketing rights in the EU, Switzerland, UK & Commonwealth of Independent States, with options for the US & Gulf Cooperation Council markets  The collaboration includes TQB3570, a proposed biosimilar version of Keytruda (pembrolizumab), with milestone & profit-sharing provisions and a framework to add up to three additional molecules   Editor’s Take: Beyond the Headlines  STADA’s partnership with Sino Biopharmaceutical strengthens its European biosimilar pipeline, with TQB3570 positioning the companies to compete in the high-value pembrolizumab market. Exclusive rights across Europe and potential US/GCC expansion could accelerate geographic reach, increase competition around Keytruda, and support broader access to oncology biologics.  Note:   The following biosimilar have been granted CHMP; however, no PR was available:  Adcomfo (omalizumab)  The post Key Biosimilars Events of September 2026   appeared first on PharmaShots.