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
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.
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.
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)
