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INSIGHTS+

Key Biosimilars Events of April 2026 

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,…
May 5, 2026

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable 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 & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
April 30, 2026

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…
November 19, 2025

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NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…
November 12, 2025

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Pfizer New
NEWS

Pfizer Reports Topline P-III (HER2CLIMB-05) Trial Data of Tukysa (Tucatinib) in Metastatic Breast Cancer (MBC)

Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…
October 15, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), which showed improved PFS by 44%,…
October 7, 2025

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Astrazeneca & Daiichi Sankyo
NEWS

Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026) sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…
September 24, 2025

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NEWS

Alkem Laboratories launches Pertuza (Biosimilar, Perjeta) Across India for Treating HER2-Positive Breast Cancer 

Shots:  Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer   In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product   Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer  Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release Related News:- CuraTeQ Biologics Reports…
September 22, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has granted BTD to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer Designation was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157) Trial showed improved PFS by 44% (mPFS: 40.7…
July 18, 2025

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