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, strengthening near-term market competition
Company: Henlius
Product: HLX319
Active Ingredient: Pertuzumab, Trastuzumab & Hyaluronidase
Reference Product: Phesgo
Reference Product Company: Genentech
Disease: Breast Cancer
Date: Apr 01, 2026
Shots:
- The Chinese NMPA has granted IND clearance to HLX319, a biosimilar version of Phesgo (pertuzumab, trastuzumab & hyaluronidase), for neoadj./adj. treatment of HER2+ early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer
- Pertuzumab & trastuzumab in HLX319 are Henlius’ HLX11 & Hanquyou, respectively, with HLX11 under review by NMPA, Health Canada, & EMA, while SC delivery is enabled by Henlius’ hyaluronidase excipient, Henozye
- Phesgo, a fixed-dose SC combination, enables trastuzumab & pertuzumab dosing in 5-8 mins without weight-based adjustment, with comparable efficacy & safety to IV regimens
Company: CuraTeQ Biologics
Product: BP11
Active Ingredient: Omalizumab
Reference Product: Xolair
Reference Product Company: Genentech and Novartis
Disease: Chronic Spontaneous Urticaria
Date: Apr 07, 2026
Shots:
- CuraTeQ Biologics has reported topline P-III trial data assessing BP11, a biosimilar version of Xolair (omalizumab) vs Xolair in pts with chronic spontaneous urticaria
- Trial met its 1EPs in CSU at 300mg, evaluating ISS7 changes at Wk. 12 across 608 pts at ~80 sites, demonstrating equivalence between BP11 & Xolair within predefined margins
- Additionally, the company is planning to complete filing of BP11 with both EMA and FDA by the end of Q2’26
Company: Apotex
Product: Denoza
Active Ingredient: Denosumab
Reference Product: Prolia
Reference Product Company: Amgen
Disease: All Approved Indications
Date: Apr 07, 2026
Shots:
- Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia
- Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph
- Denoza will be available in a prefilled syringe format
Company: Biocon
Product: Bosaya and Aukelso
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: All Approved Indications
Date: Apr 07, 2026
Shots:
- Biocon has reported the commercial launch of Bosaya & Aukelso, an interchangeable biosimilar version of Prolia & Xgeva (Denosumab) in the US, following FDA approval in Sep 2025
- Bosaya will be available in the 60mg/mL PFS format, while Aukelso will be available as a 120mg/1.7 mL (70mg/mL) single-dose vial, both for subcutaneous use
- Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation
Company: Henlius
Product: HLX05-N
Active Ingredient: Cetuximab
Reference Product: Erbitux
Reference Product Company: Eli Lilly
Disease: Metastatic Colorectal Cancer
Date: Apr 14, 2026
Shots:
- The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)
- HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions
- Cetuximab is an anti-EGFR monoclonal antibody that binds to EGFR, blocking ligand binding & signaling to inhibit proliferation, induce apoptosis, & suppress angiogenesis, while also mediating ADCC to enable immune cells to kill tumor cells
Company: Mochida Pharmaceutical and Qilu Pharmaceutical
Product: Follitropin Alfa
Active Ingredient: Follitropin Alfa
Reference Product: Gonal‑f
Reference Product Company: Merck KGaA
Disease: All Approved Indications
Date: Apr 15, 2026
Shots:
- Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan
- As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market
- Follitropin alfa is a recombinant FSH used for controlled ovarian stimulation in ART and for inducing ovulation in conditions such as PCOS
Company: Mabwell
Product: Maiweijian
Active Ingredient: Denosumab
Reference Product: Xgeva
Reference Product Company: Amgen
Disease: All Approved Indications
Date: Apr 15, 2026
Shots:
- The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors
- Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may cause severe morbidity
- Mabwell reported P-I and III results in International Immunopharmacology and JAMA Oncology, showing through head-to-head studies that the product is comparable to the reference in pharmacokinetics, pharmacodynamics, efficacy, and safety
Company: Mabwell
Product: Mailishu and Maiweijian
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: All Approved Indications
Date: Apr 16, 2026
Shots:
- Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)
- As per the deal, the partner will handle registration and commercialization in Malaysia
- While Mabwell will oversee the development, manufacturing, and supply of the products
Company: Biocon
Product: Bosaya and Vevzuo
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: All Approved Indications
Date: Apr 21, 2026
Shots:
- Health Canada has granted NOC to Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab)
- Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that the both biosimilars matched the reference product in quality, safety & efficacy
- Bosaya & Vevzuo are anti-RANKL monoclonal antibodies that will be available in 60mg/mL PFS & 70mg/mL single-dose vial presentation, respectively, for subcutaneous use
Company: Amneal Pharmaceuticals and Kashiv BioSciences
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Apr 22, 2026
Shots:
- Amneal Pharmaceuticals has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, accelerating biosimilar pipeline & strengthening US commercial position
- As per the deal, Amneal will acquire Kashiv for $375M cash & $375M equity at closing, plus up to ~$350M in regulatory milestone payments, potential royalties tied to commercial milestones, & funding of operations through closing; closing is expected in the H2’26
- The proposed deal will establish a unique global biosimilars platform by integrating Kashiv BioSciences’ development & manufacturing expertise with Amneal Pharmaceuticals’ commercial capabilities
Company: Sun Pharma and Organon
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Apr 27, 2026
Shots:
- Sun Pharma has entered into a definitive agreement to acquire Organon, growing Sun Pharma’s Innovative Medicines business & supporting its entry into biosimilars as a top-10 global player
- As per the deal, Sun Pharma will acquire Organon for $14/share in an all‑cash transaction with an enterprise valuation of $11.75B; closing is expected in early 2027
- Sun Pharma will fund the acquisition using a combination of available cash & bank financing, with the deal structured as a merger in which Organon will survive through a subsidiary merger
Company: Henlius and Organon
Product: Poherdy
Active Ingredient: Pertuzumab
Reference Product: Perjeta
Reference Product Company: Genentech
Disease: All Approved Indications
Date: Apr 29, 2026
Shots:
- The EC has approved Poherdy (420mg/14mL, IV), a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
- Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy & reference pertuzumab
- In 2022, Henlius granted Organon exclusive global commercialization rights for multiple biosimilars, incl. Poherdy, under a license & supply agreement, covering all regions except for China
Company: Gedeon Richter
Product: Tuyory
Active Ingredient: Tocilizumab
Reference Product: RoActemra
Reference Product Company: Roche
Disease: All Approved Indications
Date: Apr 29, 2026
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
Note:
- The following drug has been granted CHMP; however, no PR was available:
- Rexatilux (Biosimilar, Lucentis)
- The following drug has been approved; however, no PR was available:
- Fubelv (Biosimilar, Enbrel)
Related Post: Key Biosimilars Events of March 2026
